arisglobal · fax,crfs),electronic (e2b,web forms,emails with attachments,cdms,edc) and even voice....

ArisGlobalWhite Paper

Affiliate Safety Tracking Achieving End-to-End

Paperless Safety


© 2014 ArisGlobal LLC. All rights reserved. WPIRTOST0214.

ARISg™, ARISj™, agXchange IRT™, agXchange OST™, agXchange ESM™, agXchangeRSM™,

agNotify™, agSignals™, agComposer™, agEncoder™, Register™, agClinical™, agCenter™,

agOutcomes™, agSupply™, agWorld™, agHub™, agCapture™, agDisclosure™ and the ArisGlobal®

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pages within this presentation, as well as the presentation’s form and substance, are subject to

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transmit the information or any of its elements, such as text, images or concepts, without the prior

written permission of ArisGlobal. Trademarks, service marks, and logos (collectively the

“trademarks”) displayed on the pages within this booklet, are the property of their respective

owner. No license or right pertaining to any of these trademarks shall be granted without the

written permission of ArisGlobal, LLC (and any of its global offices and/or affiliates). ArisGlobal

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trademark rights.

EXECUTIVE OVERVIEW 4

CHALLENGES – AFFILIATE AND HEADQUARTERS 5

DELIVERING ON THE VISION – REALIZING THE PAPERLESS WORLD 7

COMPREHENSIVE SUPPORT FOR AFFILIATE SAFETY TRACKING 11

UNIQUE CAPABILITIES OFFERS FLEXIBLE SOLUTIONS 13

ARCHITECTURE TO MEET YOUR BUSINESS REQUIREMENTS 17

BUSINESS BENEFITS AND EXPECTED RESULTS 19

SUMMARY 21

ABOUT ARISGLOBAL 22

CONTENTS

Affiliate Safety Tracking

The underlying principles of clinical safety and pharmacovigilance now require an organization to

not only manage and report adverse event data, but also to analyze all available information to

identify trends and establish the safety profile of every product. It is the responsibility of every life

sciences company to collect information on adverse events and case reports from all sources and

identify adverse drug reactions and safety signals.

The reporting clock starts once any member of a life science organization becomes aware of a

safety event, regardless of their position in the company or physical location. Delays in internal

communications due to disparate time zones or unclear information can lead to incomplete

submissions to regulatory authorities or even late delivery of a required report. As the volume of

information collected in the R&D life cycle of a product continues to grow, and similarly the

volume of regulatory changes expands, today’s life science company is literally drowning in the

paper-based, manual processes traditionally prevalent in its drug safety processing and reporting.

Companies are, therefore, increasingly looking towards applications to help them optimize

processing the increasing amount of data—but in an automated, paperless way.

With most pharma companies operating in a global environment, local or regional regulatory

reporting responsibilities are typically managed by local safety offices. These offices are accountable

for local compliance and need to be inspection-ready for demonstrating appropriate tracking

systems and processes are in place for supporting local regulatory compliance. Working with

limited resources, local safety offices need to ensure timely safety submissions to their local

regulators and partners once safety cases are ready for reporting.

agXchange IRT™ and agXchange OST™ are part of ArisGlobal’s Total Safety™ suite of integrated

software solutions that enable life science organizations to deploy cost-effective, end-to-end safety

item tracking, from receipt to submission. The agXchange IRT and agXchange OST solutions allow

organizations to more closely integrate their affiliate offices into the process of collecting and

submitting safety information without the need to deploy the full power of a central safety system

at each site.

The underlying principles of clinical safety and

pharmacovigilance now require an organization

to not only manage and report adverse event

data, but also to analyze all available

information to identify trends and establish the

safety profile of every product.

EXECUTIVE OVERVIEW


Ensuring local submissions are made in a timely fashion

The global regulatory landscape facing multinational pharmaceuticals is complicated. The reporting

guidelines and timelines vary and MAHs are required to ensure all submissions are in accordance

with local regulatory requirements and partner licensing agreements. Reporting obligations differ

between FDA, EMEA, MHLW, and other National Competent Authorities. In the last couple of

years most of the global companies have come to grips with the regulatory requirements of the

major regulatory authorities, which have mandated the electronic submission of safety data for

clinical safety reports (SUSARs) and spontaneous reports (ICSRs). However, some authorities and

partners may still require reports to be submitted in paper – which must be monitored and tracked.

The challenge most companies are facing today is ensuring all the local affiliates are meeting their

local reporting obligations.

Collating and capturing all inbound safety issues

Potential safety reports come with varying detail and structure from a variety of sources. They can

be sent to the sponsor from the health authorities, co-marketing partners, literature cases, clinical

trials, potential spontaneous reports from health professionals and consumers, pregnancy registry

cases, and from other business systems such as call center applications. These cases come in a

variety of formats, including, but not limited to, paper (forms, freeform letters, literature, journals,

fax, CRFs), electronic (E2B, Web forms, emails with attachments, CDMS, EDC) and even voice. The

challenge is having a single and integrated solution for collecting all potential adverse event data.

Tracking compliance at each affiliate and partner

Because local affiliates are often isolated from headquarters and the centralized drug safety system,

MAHs have a difficult and costly time in obtaining an accurate, centralized overview of all global

safety activity. Late or incomplete submissions can have disasterous results. All internal and

external communications need to be recorded and synchronized with the central drug safety

system or have the option of bypassing the safety system (in case of partner drugs), allowing the

organization to have a centralized view of all internal and external communications.

Ensuring data quality of received reports

Over time there has been an escalation in the amount and type of data collected during the life

cycle of the product, resulting in an increase in the complexity and diversity of the systems in which

this information is captured and stored. There are two reasons for assuring data quality. First,

identifying data must be present for a case to exist, and second, sufficient data must be available to

analyze the situation. Furthermore, the current landscape has evolved to a globalized and highly

decentralized environment, challenging existing systems, data storage, monitoring and auditing.

Companies must develop reliable, proactive and easy follow-up systems.

Performing effective follow-up tracking

with appropriate documentary evidence

Regulatory compliance requires control, tracking, and follow-up over multiple events resulting from

safety cases. Tracking these events, as well as their correspondence and related documentation in

the most efficient manner, has always been a challenge for the industry. This includes follow-up

activities between the headquarters and affiliates as well as with the affiliates and their local

authorities and senders. 21 CFR Part 11 requires the tracking and auditing of all information

relevant to regulatory reporting to ensure and demonstrate compliance.

When a potential report is received by a

company representative, an assessment must

be made to determine if the information

available is a valid report regardless of the

source and format.

CHALLENGES – AFFILIATE AND HEADQUARTERS


Overseeing regional obligations and commitments to local authorities

Some jurisdictions require that all adverse events, regardless of where in the world they

occurred, must be reported. This often requires manufacturers to submit more than one report

about the same event, sometimes referred to "echo reporting.” However, other jurisdictions

require adverse event reports that have occurred within their national boundaries.

Headquarters is then faced with the daunting challenge of sorting and distributing safety reports

and keeping track of the regional obligations.

Eliminating duplicate cases prior to data entry and case processing

Consumers may file duplicate reports with the sponsor and/or the authority, leading to duplicate

adverse event reporting. Duplicate reporting can produce a false positive signal for adverse events

attributed to a particular drug. Furthermore, by scattering reporting across several receiving

systems, the quality and statistical integrity of the data could easily be compromised, in addition to

being difficult to combine, analyze and understand. The industry’s commitment to “signal detection”

and consumer confidence would be in jeopardy. Company expenditures to address the burden of

sorting through duplicate reports could require significant time, money and effort. Systems must

be able to detect duplicate cases and support duplication of appropriate portions of case items

into a new item at the user’s request.

Ensuring valid safety cases are captured to acceptable quality

standards and company SOPs

The development and use of SOPs are an integral part of a successful quality system as it

provides individuals with the information to perform a job properly, and facilitates consistency in

the quality and integrity of a product or end result. However, when a process and system is

manual, it is difficult for employees to keep up with all the changes in SOPs, policies, and other

critical documentation. Companies need to ensure their systems are up to date with the proper

enforcement controls and validation.

Each reporter of a case will have a preferred

medium of submitting information to the

MAH or sponsor. The challenge is dealing

with each report individually in an efficient

and expedited manner.


The pharmacological science of collecting, monitoring, researching, assessing and evaluating

information from healthcare providers and patients on the adverse effects of medications has a

primary mission of understanding and preventing adverse drug reactions or any other drug-related

problems. However, there are a number of complexities of delivering drug safety for companies

with a large number of affiliates. The first part of the process looks like the following.

1. Affiliates or regional centers receive potential safety reports from various sources via different

media / format. This includes structured data such as E2B data entry, online form entry, as well

as unstructured data like emails, faxes, and voice.

2. Each affiliate then needs to track receipt and follow-up communications for all potential safety

cases. This includes all communications with the consumers or health care providers.

3. Affiliates are required to provide local assessment, then forward to regional center or

the headquarters.

4. The regional center or headquarters may then have questions and queries to the affiliates.

The affiliates must follow up on these queries in a timely manner.

5. Finally, probable cases need to be transferred to the drug safety database for follow-up and

case processing.

Delays in internal communication—due to disparate time zones or unclear information, for

example—can lead to incomplete regulatory submissions or even late delivery of a required

report. As the volume of information collected in the R&D life cycle of a product continues to

grow, and similarly the volume of regulatory changes expands, today’s life science company is

literally drowning in the paper-based, manual processes reflected in their drug safety processing and

reporting – especially with information exchange with affiliates and partners. Companies are,

therefore, increasingly looking towards applications to help them optimize processing the increasing

amount of data—but in an automated, paperless way.

Multiple sources equate to multiple challenges

Efficient case handling must begin at the very source of receipt and continue through to periodic

and aggregate summary reporting. All source documents must be scanned, or even better,

electronically received and associated with the case. Wherever possible, cases should be received,

processed and distributed in a fully electronic, paperless manner. To complicate matters, as shown

in Figure 1, these reports are received from multiple sources in a variety of mediums, with variable

quality and in both structured and unstructured formats.

Companies are looking towards applications to

help them optimize processing the increasing

amount of data—but in an automated,

paperless way.

DELIVERING ON THE VISION – REALIZING THE PAPERLESS WORLD


Many companies are now realizing the

significant benefits of sharing data electronically,

including improved compliance and, perhaps

more significantly, the reduced amount of time

in performing redundant data entry.

Structured data handling

Possibly the easiest data to handle in a paperless environment is the structured data that

companies receive. The recent adoption of E2B provided an international standard whereby cases

can be received and distributed electronically, reducing the processing time significantly compared

to traditional reporting methods. After the initial resistance to electronic reporting due to the

costs and limitations enforced, many companies are now realizing the significant benefits of sharing

data electronically, including improved compliance and, perhaps more significantly, the reduced

amount of time in performing redundant data entry. This is true not only in reporting cases to the

regulators, but also to partners with whom this data needs to be shared.

Similar processing efficiencies can be gained by providing options for remote online data entry for

both spontaneous and clinical safety reports. Investigators, affiliates, license partners and CROs can

all be provided direct online access.

Unstructured data handling

Unstructured data, often unsolicited, will typically be received in the form of phone calls, faxes or

emails. Many companies, especially those conducting clinical trials, try to structure incoming reports

by creating fax and email templates that can be scanned and indexed automatically. Using OCR

technology, it is relatively straightforward to create a fax template whereby the study, patient

number, investigator and product can be extracted and indexed automatically (if typed on the

faxed form).

Some advanced applications can automatically process incoming faxes and emails so that the

manual process of scanning in these faxes also becomes redundant. In this case, the received

information is automatically presented to the user in an electronic inbox from where this

information can be further processed.

Figure 1. Multiple data

sources do not always arrive

neatly packaged for data

entry or review


For documents with no such template, a high level of process optimization is achieved by offering

tools to perform online reviews. Faxes and emails received are automatically created as source

documents, while the online review tools allow users to assess these documents, redact and split

them, and, if necessary, complete initial data entry and assessment in a variety of formats.

Item handling

When a potential safety report is received by a company representative, an assessment is made to

determine if the information available is a valid report. Regulatory agencies have specified a

minimum set of criteria, including an identifiable patient, reporter, drug and event. If the required

data is not available, the MAH has an obligation to perform active follow-up. Even if the received

information indicates that an adverse event report does not need to be created, the information

captured and the follow-up processes need to be maintained and archived.

When a potential report is received by a company representative, an assessment must be made to

determine if the information available is a valid report, regardless of the source and format.

Case processing

Every company has defined its own processes and timelines for processing adverse event reports.

As expected, processes typically vary depending upon the source and seriousness of the report

and any specific regulatory commitments. Often, reports are routed to specific specialists based on

user-defined criteria. For example, products from a particular therapeutic class are routed to an

appropriate specialist for assessment. Using the same logic, it is possible to monitor specific

drug/event combinations.

To improve the case processing speed and efficiency of the case-handling process, users need to

have online and secure access to the source documents, which are typically stored as images and

are stored with the case. This capability is especially relevant for companies that have

geographically distributed case processing, as users will no longer have to wait until the paper

source documentation arrives to start processing the case.

Automated workflow can provide many additional benefits as cases are routed to individuals for

further processing. To fully realize the benefits of workflow, reports should be routed based on the

content of the case data. Workflows, therefore, need to be flexible and effortlessly adaptable as

situations change.

Not only will workflow help in processing cases in a more efficient automated way, it can also be

used to facilitate compliance with reporting timelines by ensuring that serious and/or reportable

cases are presented in a more prominent way to the user.

Workflow also supports 21 CFR Part 11 compliance by recording who completed each activity and

when. The same information can also be used for tracking of metrics and key performance indicators,

helping companies to manage departments and functions more efficiently than ever before.

Communication and case follow-up

Following up on the safety report is a major function of pharmacovigilance, and it is important to

demonstrate to the regulators that every possible effort was taken to investigate possible adverse

event reports. This means that strong communication tracking tools, including standard letter

generation, fax and email integration are critical.

Often reports are structured and delivered

electronically as now is typical with E2B.

However, many reporters will deliver

information in an unstructured format such as

faxes, email or via the phone.


Case distribution

Perhaps some of the greatest efficiencies can be gained in the distribution of case reports to third

parties, including regulatory agencies, license partners and other stakeholders. In the past, reports

were distributed manually using postal and fax technology.

E2B has automated electronic distribution to a certain extent, but its use is limited to those

partners who can receive the E2B standard. Case distribution now needs to incorporate the

different mediums available, including fax and email. Furthermore, the E2B standard has been

developed keeping regulatory needs in mind. It has emerged that when exchanging information

with partner companies, the E2B standard is not always sufficient and that additional information

also needs to be exchanged—hence the need for an extended E2B format.

Extending this further, it is not sufficient for companies to only distribute the reports. They must

have evidence that the reports were distributed and preferably track the receipt. Of course, this

can result in a huge administrative effort.

Of greater concern, it remains a reality that this information is rarely available in a single location

and more typically is held with each affiliate. Bringing this data to a central database remains a

challenge. Typically, companies are reluctant to provide affiliates remote access to the central

pharmacovigilance system and are seeking systems that offer components and tools for affiliates to

track submissions and responses from the regulators.

Once a case has been identified as a

reportable case, it needs to be distributed to

all affiliates, authorities and stakeholders such

as investigators.


To address today's business, regulatory, operational, and economic challenges, ArisGlobal has

developed Total Safety™ — a comprehensive suite of integrated software solutions to enable life

science organizations, regardless of status or size, to implement effective domestic and global

pharmacovigilance, clinical safety and risk management programs. The Total Safety suite is comprised

of industry-leading solutions used globally by more than 300 direct and indirect organizations.

Total Safety includes agXchange™, as shown in Figure 2, the modular gateway for extended

electronic exchange. agXchange ESM™ (E2B safety submissions module) supports the E2B

standard for electronic communication of safety case data such as ICSRs, SUSARs, attachments

and periodic reports. agXchange IRT™ (Inbound Receipt and Triage) enables inbound

receipt and triage of adverse event information securely and efficiently from diverse

constituencies: affiliates, co-development partners, consumers, healthcare providers, CROs and

headquarters' staff. Information received is triaged prior to evaluation and only upon

determination is data transferred into the safety system. agXchange OST™ (Outbound

Submission Tracking) is a solution for regional safety tracking and compliance management. Finally,

agXchange SIR™ (Safety-to-Investigator Reporting) enables organizations to automate the

distribution of clinical safety reports and other clinical documentation to investigators, central IRBs,

ethics committees and other stakeholders.

Total Safety offers a comprehensive suite of

integrated solutions to enable life sciences

organizations to implement effective domestic

and global pharmacovigilance, clinical safety

and risk management programs.SideBar

COMPREHENSIVE SUPPORT FOR AFFILIATE SAFETY TRACKING


Figure 2. Overview of

agXchange modular

gateway for extended

electronic exchange

Inbound item receipt

The agXchange IRT module enables organizations to more efficiently collect and process safety

information from any source, including affiliate locations, license partners, CROs, physicians and the

patient/consumer. As shown in Figure 3, agxchange IRT supports capturing both structured and

unstructured potential adverse event reports from a variety of sources over different

communication media, including fax, email, postal mail, an electronic data interchange gateway, EDC

systems, or online Web form entry. Available information/documents—e.g., faxes, attachments,

emails, Web form, etc.—are automatically converted and stored as source documents.

Assessment/triage

Once an item is received, the authorized user can enter an initial report assessment to determine

if the required data is available for a valid adverse event report. This can be supported using a

simple assessment/triage form with a limited set of data entry, or the complete assessment,

including entry of the available case data. Assessment forms can be designed to support customer

triage processes. Different forms may be utilized for clinical, post-marketing and other reports. If

there is insufficient data or the data quality is suspect, the user can track any follow-up activities

and/or queries related to the received report.

Communication/notification tracking

agXchange IRT and agXchange OST supports communication with external and internal parties as

part of follow up with queries on the received items. Fully integrated with email and fax systems,

the communications module allows users to send and receive communications and track follow-up

activities. Centralized tracking of communications between the safety department and the affiliate

locations ensure that requests for clarification or additional information are adequately monitored.

Upon assessment, appropriate individuals can automatically be notified about the received report.

Flexible workflow

An internal workflow can be defined to process the inbound item. The workflow can be configured

to support both local and headquarter processes. After completion of all workflow activities,

based on the item assessment, the item may be disposed appropriately. The assessment

determines whether to create a new case in the safety database, add the report as a follow up to

a previous case, forward it to another system (e.g., a product complaint or medical inquiry system),

or archive the report for future reference.

Ready-for-reporting case list

Upon completion of processing in the safety system, cases are automatically routed to agXchange

OST for final review, reporting decision and submission by the local offices. The listing distinguishes

between submissions to health authorities and to partners. For each submission, the report in the

appropriate format is available together with the cover letter. The user may make the reporting

decision at the case level or at the recipient level. This way, the local office can get an additional

level of control over submission to only qualifying recipients based on local assessment.

Submission

Upon completing the reporting decision activity, the reports are submitted using the appropriate

media associated with each recipient. The system supports automated submission by fax, email, or

(in conjunction with agXchange ESM) via E2B gateway.

agXchange OST enables affiliates to track

outbound submissions to authorities and track

all communications including authority requests.

Any delays in submission or failures to report

are instantly notified to central drug safety—

giving complete visibility to all safety activity at

all affiliates worldwide.


Figure 3. agXchange IRT supports receipt of

structured (e.g., E2B) and unstructured data

(Fax, email, paper, etc.) and automatically list

received reports by affiliate and partner.

Plan globally, act locally

All MAHs today are required to have an appropriate system of pharmacovigilance in place and a

pharmacovigilance (PV) plan for each authorized product, describing routine pharmacovigilance and

risk minimization activities. According to ICH E2E, the pharmacovigilance plan should be based on

the product safety specification, which summarizes the safety profile of the medicinal product at the

particular point in time of its life cycle, and proposes actions to address known safety concerns.

One of the biggest advantages of ArisGlobal Total Safety suite is the ability for the company to

create a global and comprehensive safety and pharmacovigilance plan while allowing the affiliates to

manage their own safety data using agXchange IRT and OST. The affiliates keep track of their safety

items and tracks communication between all the stakeholders (investigator, CRO, headquarters).

The affiliates are empowered to enter region-specific details and have a Local Reference Number

(LRN) assigned. Assessment is done using pre-configured workflow with activities at the affiliate

level and/or headquarter level. Furthermore, the affiliates can manage their submissions to various

parties once case processing in the safety system has been completed. Using agXchange IRT and

OST, headquarters will always have visibility into the affiliates with a complete audit trail for 21 CFR

Part 11 compliance.

Holding area of all potential safety

items before promoting to safety system

Before information gets entered and stored in the corporate safety system, best practices call for a

consolidated receipt and triage of all potential safety items prior to promotion to the safety

database regardless of source. Authorized users should collect all the required information

regarding the safety case and identify adverse events to be imported into your safety system as a

new case, follow-up or new source document.

agXchange IRT is the solution for tracking and processing potential safety reports from all sources

before getting promoted to the safety system. The system enables data entry into a standardized

AE form for review and approval with complete controlled import into the safety system. During

assessment, items are classified as new case, follow-up or new source document for prior cases.

agXchange IRT ensures all required fields are populated with valid data before it is promoted to

the safety system. The system also helps detect potential duplicate or follow-up checks against

agXchange IRT and the safety system. If items are not promoted to the safety system, they are

archived in agXchange IRT. This ensures the safety system is clean with complete and valid

information and improves user productivity.

Clinical SAEs:

Direct SAE Entry or Staging area for Electronic Data Capture

Companies need to collect information on adverse events and case reports from all sources and

identify adverse drug reactions and safety signals. Even though some sources may seem more

reliable than others, all of the items need to be reviewed and triaged prior to importing them

directly to the safety system. With the growing adoption of electronic clinical trials, a number of

companies rely on electronic data capture (EDC) to capture clinical data directly from study sites.

However, many sites continue to fill out and fax SAE separately from the EDC system.

One of the biggest advantages of ArisGlobal

Total Safety suite is the ability for the company

to create a global and comprehensive safety

and pharmacovigilance plan while allowing the

affiliates to manage their own safety data using

agXchange IRT and OST.

UNIQUE CAPABILITIES OFFER FLEXIBLE SOLUTIONS


agXchange includes integrated communications

tracking between centralized safety department

and offsite locations

agXchange IRT is the staging area for the receipt and review of all clinical SAEs prior to disposition

to safety systems. An IRT online form can be deployed to the study site for entry of SAEs (to

replace the paper faxing today). With appropriate integration, this form can also be accessed and

submitted directly from the EDC system in use at the study site. In either case, agXchange IRT can

validate the data automatically and can have the user manually review and assess the case before it

is imported into the safety system. agXchange IRT provides a complete audit trail of what has

been received from the EDC system and can track any follow-up activities from the partner,

investigator, CRO and regulatory authority. agXchange IRT ensures all required fields are populated

with valid data before it is promoted to the safety system. Companies may choose to pass

through some items directly to the safety system, depending on the source. agXchange IRT

enables companies to create a single point of capture for all safety data, regardless of source, and

leverage agXchange as the holding area.

Enhancing collaboration with partners and manufacturers

Many life science companies create strategic partnerships and alliances for a specific therapeutic

area or to market a product in specific geographic locations. Companies must be able to

collaborate and exchange critical safety information. As partners receive safety data, they are

obligated to send the information to the MAH. Most companies rely on manual processes and

paper when sending the information to the partner and often times do not keep a complete audit

trail of what has been received and what has been sent to the partner.

agXchange IRT enables the partner to capture the safety information using a simple dynamic

form and send the information directly to the MAH. Upon assessing the case as a partner case,

agXchange IRT can be used to directly notify the partner and send the case information with

the notification. The company can thus avoid creating and processing partner cases in the

safety system.

Affiliate compliance monitoring—without the

costs of a full safety system

The affiliates only care about the products they market and for the submissions they make to their

local authority. In many cases, headquarters will send the affiliates all the safety reports and rely on

the affiliates to sort through the reports to determine which ones are applicable. Furthermore,

affiliates may need to add local content before it goes to the authority. However, in many cases

affiliates may not have access to the central safety system because of licensing costs and training.

However, they are still responsible and held accountable for all reporting obligations.

Using agXchange OST, companies send the affiliates the safety reports that apply to them and with

a simple, user-friendly interface (shared with agXchange IRT), the affiliate safety officer can add /

review the case data/report, make a reporting decision, enter any comments/reasons, and attach

local cover letters and supplementary data/documents required for the submission. For example,

the affiliate in France can add the French Imputability without accessing the safety system.

agXchange OST maintains the submission status and keeps a detailed audit trail of when the

submissions are made and if they are late, and submission information is automatically updated in

the central safety system with the details (i.e., reason for being late). The benefit is achieving

compliance monitoring without the costs of deploying the safety system to the affiliates.


Enhancing call center operations

Life science companies will receive adverse event information from different sources such as health

professionals, clinical investigators, patients, through review of literature articles, etc. Some potential

safety issues may also be received via call center operations set up for general product information

or for specific product use support. In most cases, such reports from the call center operation are

faxed to the safety department and then manually processed.

Using an interface to agXchange IRT, call center operators can utilize online forms for capturing

data pertaining to potential safety issues and submit the form to IRT electronically for further

assessment and promotion to the safety system. Such an interface leads not only to process

efficiencies in the handling of items received from call centers, but also to improved tracking and

reconciliation of all such items from receipt to submission.

Literature reports and research

Safety departments are obligated to perform regular literature scans to look for any reported

safety issues related to their company’s products. Most companies have a dedicated function to

research literature and determine which articles are applicable and reporting potential adverse

events. In many companies, this entire process and communication between the literature research

department and safety is mostly manual and done via email with no audit trail. Active management

and coordination of the timely distribution of this information to the appropriate parties in the

proper context is crucial for successful global medical information sharing and management, and

mitigates the risk of both safety and legal problems.

agXchange IRT can be used for receiving literature attachments with email, any communication

between the safety and medical communications departments, and the assessment done on

specific literature articles. Using workflow, the company can implement unique business processes

and needs for reviewing and assessing literature reports. Users select which items are potential

safety items and which need further investigation and follow up. agXchange IRT automatically

sends the information to the appropriate stakeholders and keeps track of all the follow-up activities

and communication. Users also have the ability to attach inquiry source documents (i.e., the PDF

version of the article). Once identified as a safety item, agXchange IRT sends the information to

the safety system.

This allows documented tracking of literature search results from receipt to assessment and

appropriate disposition in a 21 CFR Part 11 system, leading to much improved inspection readiness

with regard to literature searches and resulting safety processing,

Using an interface to agXchange IRT, call center

operators can utilize online forms for capturing

data pertaining to potential safety issues and

submit the form to IRT electronically for further

assessment and promotion to the safety system.


Outsourcing using a pass- through system

During a questionable economy, management is demanding to “do more with less.” As a result,

companies have been outsourcing the receipt and triage of AEs from clinical studies to CROs.

CROs are responsible for capturing and tracking a certain amount of fields for the sponsor

company. The CRO is typically responsible for following up with the investigator on gathering the

details – which can be very time consuming and expensive. For many studies, the data fields and

communication information is usually maintained in an Excel spreadsheet or simple Access

database. Once the information is complete, the CROs manually feed this information to the

sponsor company for data entry into the safety system.

The pharmaceutical company can give the CRO limited access to agXchange IRT for capturing

the required fields. agXchange IRT can also facilitate the CRO with the communications and

follow-up activities with the investigator. Once all the information is assembled and captured,

further assessment can be done in activities accessible to the sponsor. Upon final sponsor

assessment, agXchange IRT can send the data directly to the safety system. This delivers

tremendous benefits to both the CRO and pharmaceutical company as the sponsor does not

need to worry about giving the CRO access to the safety system, eliminates double entry, and

delivers a compliant audit trail.

The pharmaceutical company can give the CRO

limited access to agXchange IRT for capturing

the required fields.


Safety system agnostic

agXchange is integrated with ARISg, the world's leading pharmacovigilance and clinical safety

system with more than 300 life-sciences companies maintaining their critical safety data in ARISg.

However, agXchange IRT and OST can be integrated with other third-party safety systems.

agXchange IRT and OST can receive, transfer and synchronize items to other safety databases.

J2EE-based deployment

The J2EE platform provides a framework for deploying scalable, secure, and cost-effective business

applications. agXchange IRT and OST leverage the existing J2EE infrastructure for delivering a

solution that can handle large volume transactions, security, scalability, concurrency and

management of the components.

No client-side installation

The agXchange solution requires only a standard Web browser, which means there is no software

distribution or maintenance on the user’s desktops. The application does not use Active X controls

or applets.

Configurable workflow, assessment forms, communication templates

The workflow activities can be configured for the company’s business logic for routing cases

through the data entry and assessment process. Furthermore, the system accommodates multiple

workflows—based on product type, source, receiving center, sender, etc. All the pre-configured

forms and templates can be tailored for any business and operational need.

Data model to accommodate safety case

agXchange uses a standard and open database with a data model to support data exchange with a

company’s safety system. The data within the system can automatically be synchronized with the

safety database.

RightFax server support

Open Text Fax Server (RightFax) is a proven market leader in fax server, document delivery and

fax software. The integration automates and delivers the flow of a full range of fax, paper and

electronic documents and data directly and securely into and out of the agXchange system.

Built-in OCR capabilities

Optical character recognition (OCR) is the mechanical and electronic translation of images of

handwritten, typewritten or printed text (usually captured by a scanner) into machine-editable text.

Since data does not arrive neatly packaged and categorized for data entry or review, agXchange

can extract key data fields from the document using OCR and displays it neatly for the user. These

index fields can then be utilized to route the item appropriately in the workflow.

Built-in document management system and Documentum support

agXchange stores and maintains documents for any stage in either the built-in document

management system (DMS) or an existing repository such as Documentum. This seamless

integration allows users to access/open documents from the Documentum repository, add

documents to the repository, and reference Documentum documents in all inbound and

outbound communications.

ARCHITECTURE TO MEET YOUR BUSINESS REQUIREMENTS


System administration

agXchange was designed and developed using the latest standards for interoperability and provides

comprehensive admin functions for user maintenance, partner setup, security definitions, audit trail

reports, form designs, index fields and custom fields. agXchange supports email standards such as

Simple Mail Transfer Protocol (SMTP) and Post Office Protocol (POP) for receipts and

communication by email.

SaaS offering

agOnDemand™ is the ready-to-use, web-based, hosted software service that enables all companies

to use agXchange on a subscription basis — without the investment in new software, hardware, or

even new application and infrastructure support staff. agOnDemand delivers the complete

application functionality that enable life science companies and CROs, regardless of status or size,

to implement effective pharmacovigilance, clinical safety and risk management programs. Using

agOnDemand, companies are able to quickly deploy either the entire suite of functionality or a

subset of functionality in a secure, hosted environment.

Using agOnDemand, companies are able to

quickly deploy either the entire suite of

functionality or a subset of functionality in a

secure, hosted environment.


agXchange IRT allows organizations to more closely integrate their affiliate offices, call centers,

study sites (or CROs) into the process of collecting and processing safety information without

requiring access to the centralized drug safety system. Information can be received in many

different structured and unstructured formats, and headquarters then has the opportunity to

review and assess the available information prior to promoting the case to the global safety

database for further processing. In conjunction with agXchange IRT, agXchange OST enables

automated handling of all safety items from initial receipt to final submission to appropriate

regulators and partners. agXchange delivers the following short- and long-term benefits.

• Maintains compliance and reporting requirements while lowering

costs – agXchange IRT takes advantage of the inherent productivity benefits of electronic

communication, serving to decrease the amount of time organizations spend collecting and

verifying safety information and increase their ability to report complete and accurate safety

case information on time.

• Increases inspection readiness at the affiliate level – agXchange IRT and

OST provide a comprehensive local tracking system for all incoming potential safety items and

outgoing submissions.

• Recognizes operational efficiencies – agXchange enables implementation of

common processes across local safety offices and streamlines internal operations through

standardizing and simplifying key processes.

• Reduces paper throughout the enterprise – agXchange IRT interfaces to

email, fax and online entry systems, eliminating manual paper handling across offices and co-

marketing partners.

• Offers an option for Software as a Service (SaaS) deployment – Using

agOnDemand, companies are able to deploy agXchange IRT and OST in a secure, hosted

environment without the investment in new software, hardware, or even new application and

infrastructure support staff.

• Drives continual improvements in both collection and reporting

safety data – During this assessment phase, organizations can assess whether information

received should go through the extensive safety-review workflow and follow-up action can be

forwarded to designated individuals when appropriate.

• Creates a single point of capture for all safety data regardless of

source – Using a single system and process, companies are able to efficiently collect and

process safety information from any source, including affiliate locations, license partners, CROs,

physicians and the patient/consumer.

• Improves affiliate productivity – Using an intuitive portal, local safety officers

ensure timely safety submissions to local regulators and partners once their applicable safety

cases are ready for reporting.

BUSINESS BENEFITS AND EXPECTED RESULTS


• Enriches data integrity and completeness of safety data –

agXchange IRT ensures all required fields are populated with valid data before being

promoted to the safety system. Affiliate-level data entry and assessment reduces redundant

data entry, duplicate items, and errors in submission.

• Enhances relationship between headquarters affiliates and

partners – agXchange IRT allows organizations to integrate their affiliate offices and

partners into the process of collecting and processing safety information without requiring

access to the centralized drug safety system. agXchange OST provides a single, consolidated

area for affiliates to make reporting decisions and add local content, enhancing local reporting

compliance. Partners capture the information and pass it through to the sponsor without

processing it in their safety system.

• Makes best use of your safety system – Initial triage eliminates non-cases

from being forwarded to and processed in the corporate safety system, and assigns

appropriate priority for cases to be processed, increasing case handling efficiencies in a

company’s safety system.

• Integrates with other business applications – Using an open-based J2EE

architecture, agXchange integrates with third-party applications such as safety systems,

Documentum, email applications, fax servers and other business critical applications.

ArisGlobal delivers a comprehensive system for

affiliate management of safety issues, without

the need to deploy the full power of a central

safety system at each site.


Adverse event reports are constantly being received by sponsors, distributors, and marketing

authorization holders in a variety of structured and unstructured formats with differing levels of

quality from many sources. All these reports need to be reviewed, categorized and assessed for

case processing and reporting. Collaboration between departments, meeting deadlines, and

providing accurate content to produce a fully compliant report is essential. This complexity leads

to the need for a fully integrated paperless pharmacovigilance suite to capture, triage, assess, and

dispose safety data—while controlling the inevitable costs involved.

agXchange IRT and OST are part of ArisGlobal’s Total Safety suite of integrated software solutions

that enable life science organizations to deploy cost-effective, end-to-end safety item tracking, from

receipt to submission. agXchange IRT allows companies to more efficiently collect and process

safety information from any source, including affiliate locations, license partners, CROs, physicians

and the patient/consumer. agXchange OST enables consolidated affiliate-level review, reporting

decision, submission and tracking of all local case reporting. Together, agXchange IRT and OST

enables more efficient compliance monitoring and helps implement effective domestic and global

pharmacovigilance, clinical safety and risk management programs.

SUMMARY


ArisGlobal is a leading provider of integrated software solutions for pharmacovigilance and safety,

regulatory affairs, clinical research and medical information. Since 1985, the company has become

the chosen partner of many of the world’s leading pharmaceutical, biotechnology, and medical

device companies. Today, more than 300 life science companies worldwide rely on ArisGlobal

software to meet international regulatory requirements, manage and mitigate risk, improve

operational efficiencies and easily share mission-critical information on a global basis.

For information on ArisGlobal solutions, visit www.arisglobal.com or email us at

[email protected]

ABOUT ARISGLOBAL


CORPORATE HEADQUARTERS

ArisGlobal, 1266 East Main Street, Stamford, CT 06902, USA

Tel: +1 203 588 3000 Fax: +1 203 356 1673

Email: [email protected]

UNITED KINGDOM

ArisGlobal UK Ltd, 5-6 Shenley Pavilions, Chalkdell Drive,

Shenley Wood, Milton Keynes MK5 6LB

Tel: +44 1908 506075 Fax: +44 1908 503027

BELGIUM

ArisGlobal BVBA, Groote Steenweg 323

B-2600 Berchem, Belgium

Tel: +32 3 500 9678

ITALY

ArisGlobal GmbH, Via degli Ausoni 7/a Palazzo della Cerere

00185 Roma – Italy

Tel: +39 0649270868 Fax: + 39 0649389184

GERMANY

ArisGlobal GmbH, Inselkammerstrasse 11,

D-82008 Unterhaching

Tel: +49 89 666 0840 Fax: +49 89 666 08418

IRELAND

ArisGlobal Ltd, Embassy House, Herbert Park Lane, Ballsbridge

Dublin 4, Ireland

Tel: +353 1 9052430

INDIA

ArisGlobal Software Pvt. Ltd., SKR Towers, #19/2, 15th Cross,

JP Nagar 4th Phase, Dollars Colony, Bangalore - 560078, India

Tel: +91 80 6621 2747 Fax: +91 80 6621 2500

JAPAN

ArisGlobal KK, TK Shin-Toshin Bldg., 6F1-23-1, Nishi-Shinjuku,

Shinjuku-ku Tokyo, 160-0023 Japan

Tel: +81 3 6304 5462 Fax: +81 3 6304 5463

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