Orbis Clinical

Providing the world’s leading biopharmaceutical organizations with

drug safety, regulatory affairs and quality assurance expertise essential in

treating devastating disease.

About Orbis Clinical Orbis Clinical is a consulting firm focused on providing expertise in Regulatory Affairs,

Quality Assurance, Drug Safety, and Risk Management. We deliver highly qualified consultants to enable our clients to solve the key tactical and strategic challenges they face.

Located in the greater Boston area, we have been servicing clients nation-wide for over five years. Recently named by Inc. 500 as one of the 500 fastest growing companies.

Our niche expertise has resulted in successful working relationships with the leading Pharmaceutical and Biotechnology companies worldwide. Our current client portfolio includes a wide array of small, midsize, and large Fortune 100 companies.

Orbis Clinical is focused on delivering flexible, client-driven solutions to meet the expectations, timelines, and deliverables of our clients.

In addition to our currently engaged consultants and subject matter experts, we maintain a virtual bench of hundreds of top quality resources that can be employed as needed in a timely fashion.

Inc.500 Recognition Ranked 456th on the Inc. 500 “Fastest Growing Companies by Revenue” list between

2005 and 2008. Ranked 16th in Boston-Cambridge-Quincy region Ranked 39 in the Health industry.

http://www.inc.com/inc5000/2009/company-profile.html?id=200904560

Year 2009

Industry Health

Founded 2004

Growth 566.9%

2005 Revenue $1.4 million

2008 Revenue $9.1 million

Employees 72

Services and Offerings

Drug Safety Risk Management Regulatory Quality Assurance

-AE/SAE Case Processing

-Clinical/Post-Marketing Case Review

-Medical Coding

-Medical Monitoring

-Narrative Development

-Aggregate Data Review

-Signaling/Trending

-Periodic Safety Update Reports

-Label/PI Development,Review

-Risk Evaluation and Mitigation Strategies

-Risk/Benefit Analysis

-Risk Management Plans

-Epidemiology

-Pharmacoepidemiology

-Health Economics and Outcomes Research

Submissions:-Content development of all regulatory submissionsOperations:-Indexing and Cataloguing-CTD, eCTD and SPL formattingMedical Writing:-Writing and review of all regulatory documentsCMC:-Strategy, operations, and submissionsAdvertising, Labeling, & Promotions:-Development, guidance, and review

-Project Management

-Standard Operating Procedure development and review

-Compliance

-Process Improvement

- Domestic and Rest-of-World GxP Auditing (21 CFR Part 11)

Epidemiology and Health and Economics Research Studies

Regulatory Affairs PracticeOur Regulatory Affairs Practice has dedicated internal resources to meet the mission critical and often timely challenges our client’s face.

Orbis Clinical has the global regulatory expertise to meet your analytical, strategic and operational needs. We align the right capabilities with your projects to help you protect your drug development investment. Ultimately, we know that accurate, timely submissions are key to Regulatory success.

SERVICES INCLUDE:

Global Submissions (IND, IB,CSR, NDA, BLA,MAA, etc) Regulatory Operations (eCTD, CTD, SPL) Global Labeling (All areas of clinical and post marketed labeling) Regulatory/CMC Medical/Regulatory Writing

Quality Assurance Practice

SERVICE OFFERINGS

Quality assurance Quality control Document control: review, writing, and template

development ISO Compliance Mock FDA pre-approval inspection audits On-site FDA inspections FDA 483 response preparation and review SOP development and review Policy development, validation guidelines, validation

plans, test plans and procedures Process Improvement Project Management Training and knowledge transfer

Orbis Clinical has the Quality Assurance expertise to assist pharmaceutical and biotechnology firms with auditing and improvements relative to Good Clinical Practices, GCP, Good Laboratory Practices, GLP, and Good Manufacturing Practices, GMP.

AUDITING CAPABILITIES

Internal and external, domestic and international GxP auditing (21 CFR Part 11) of:

Manufacturing facilities Clinical sites CROs, investigators, monitors,

suppliers, and study sites QC laboratories Contract laboratories GLP facilities and analytical

laboratories Quality departments

Drug Safety PracticeOrbis Clinical retains dedicated consultants within drug safety and pharmacovigilance to augment existing teams, outsource spikes in workload, or to bring an added level of subject matter expertise to your organization. Orbis Clinical provides the expertise to assist in the development and management of your clinical and post marketed safety programs to ultimately ensure patient safety through efficient and effective processes.

AREAS OF EXPERTISE INCLUDE:

MEDICAL ANALYSIS

• Physician medical review and signal detection• Aggregate Data Review• Literature reviews and summaries• Current treatment utilization patterns

REPORTING

• Initiation of reports (MedWatch 3500A, CIOMS I)• Completion of periodic safety update reports (PSURs) and periodic adverse drug experience reports (PADERs)• Preparation of Drug Safety portions of IND/BLA/NDA/ad hoc reports

STRATEGIC SAFETY CONSULTING

• Gap analysis and process improvement assessments• Benefit-risk analysis• Strategic planning for the growth of your safety departments

AE/SAE CASE PROCESSING

• Call center support• Event data entry, logging and tracking• Coding (MedDRA, WHO Drug)• Legacy case data entry• Analysis of Similar Events (AOSE)• Narrative Writing

Risk Management PracticeOrbis Clinical aims to optimize the success of your products by identifying the possible risks and benefits associated with the processes of development, manufacturing and distribution.

SERVICES INCLUDE:

RISK – BENEFIT ANALYSIS

• Integration Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE)

• Identification of potential benefits and risk to target populations

• Epidemiologic studies and outcomes• Health and Economic Outcomes Research reports

RISK EVALUATION and MITIGATION STRATEGY (REMS)

Drafting, writing, and reviewing REMS for FDA submittal All sections of REMS templates to include:

Medication Guide or PPI, Communication Plan, Elements to Assure Safe Use, Implementation System, Timetable for Submission

RISK MANAGEMENT PLAN

• Design and evaluate RMPs and risk response plans

• Establish risk reduction goals • Define and implement SOPs• Risk minimization action plans and post

marketing safety strategies• Pharmacovigilance plans (ICH E2E)

RISK MAP

• Guidance and assistance regarding clinical trials, regulatory submissions, labeling, and commercialization strategies

• Development of educational information and campaign strategies

Epidemiology and Outcomes

Epidemiologic studies

Cost, quality, & outcome measurement

Effects of health insurance product design

Analysis of health care policies & regulations

Reimbursement, optimal pricing and utilization

studies

Cost-Minimization, Cost-Effectiveness, Cost-

Benefit, and Cost-Utility Studies

Regulatory cost-benefit and impact analysis

Our goal is to assist decision makers in acquiring the necessary information regarding the risks, benefits, costs, and acceptance of their products in order to make informed decisions about how to position those products in the marketplace.

Orbis Clinical Consultants can assist in the following areas:

Value-based pricing

Economic Assessments

Clinical Trial-Based Services

Analysis and modeling of clinical trial

data

Clinical trial outcomes data collection/

data management

Post-Approval/Phase IV Studies

Evaluation of data from clinical trials,

administrative claims, epidemiologic

surveys, and market research studies

Physician Practice

Orbis Clinical has created a Drug Safety Physician Practice to further assist our Clients within Pharmacovigilance and Risk Management.  We have dedicated internal resources focused on expanding our Operational and Analytic capabilities at the physician level.

We have engaged with our Clients across their Global PharmacovigilanceDepartments.  Whether providing teams of experienced physicians or outsourcing entire projects for remote work, our Physician Practice has provided the high level expertise our Clients require.

SUCH HIGH LEVEL EXPERTISE INCLUDES:

Medical review REMS Regulatory response Product Lifecycle Management Benefit risk assessments Risk management planning Signal detection Pharmacoepidemiology

Orbis Clinical Engagement Model

Our approach: – Listen – Consult – Partner.

We Listen to our clients to understand their issues and opportunities

We consult with our clients to discover the best solutions for them We partner with our clients to introduce the right solution at the

right time

Properly Structured: Tactical or strategic, on-site or remote, time and materials or fixed price and deliverable: Orbis Clinical will develop an approach that best suits your business environment.

Orbis Clinical Case Studies

Our client needed a flexible staffing solution in their clinical Quality Assurance group to address:

- The surge in clinical trial activity this group was experiencing.

- The need to build a reliable core of full time GXP employees.

Client: A small biotechnology company

Location: Greater Philadelphia

Services provided: Orbis Clinical provided a “bench” of experienced GXP consultants to be deployed as needed across the US. These consultants worked primarily in support of a Phase III trial. Key consultants were identified by the client and transitioned to full time employees over time as means of building the full time core of GXP employees.

Orbis Clinical Case Studies

Various tactical opportunities to provide experienced GMP and GCP consultants as needed to assist with various Phase I-IV trials.

Established clients located in NJ, PA, and CA.

Services provided: Orbis Clinical has deployed a variety of individual QA auditors to augment existing client teams over the last 18 months. These resources have worked in a variety of capacities: at the client site focused on internal audits, remotely at trial sites, auditing labs, manufacturing sites, etc.

Orbis Clinical Case Studies

Client required a senior writing team for the time-sensitive development of an sBLA.

Client: Growing Biotechnology company

Location: Philadelphia

Services Provided:

Orbis Clinical quickly deployed an experienced four person team of senior regulatory writers to properly and effectively develop sections 2.7.3, 2.7.4, and 2.5 of a critical sBLA within a two week period of time. This time sensitive effort was completed on-time and under budget and was delivered to the FDA within days of completion.

Orbis Clinical Case Studies

Client in need of complete reengineering of product safety and pharmacovigilance unit to address serious regulatory concerns.

Client: An Established Mid-Western Pharmaceutical Company

Location: Chicago, IL

Services provided:

Orbis Clinical deployed a 15 person team of senior safety associates, senior safety scientists, and senior safety physicians to benchmark current practices, develop a roadmap to regulatory compliance, and, with our client, work to properly implement these changes in a time sensitive, user friendly fashion. Within months of completing this a regulatory audit was conducted by the EU which our client was well prepared for. 

Orbis Clinical Case Studies

Provide team of 15 Drug Safety consultants with legal documentation experience to assist client with a high-profile drug litigation project.

Client: Major Pharmaceutical CompanyLocation: Tri-State Area

Services Provided:

Orbis Clinical was retained by a client to assemble a 12-15 person team of drug safety professionals (depending on case load) to help its legal department with preparation of responses to Summons & Complaints. Based on specific client challenges, Orbis Clinical provided a team comprised of Data Registrars, Medical Report Coordinators, and Drug Safety Specialists. As a niche provider of drug litigation services, these contract consultants were provided under a Clinical Service Agreement (CSA).

Orbis Clinical Case Studies

Client in need of labeling expertise for a planned NDA .

Client: Growing Biotechnology companyLocation: Philadelphia Area

Services Provided:

Our client had aggressive deadlines set for the creation of a new label in support of an upcoming NDA. Their organization lacked the internal expertise to effectively develop the label and meet Agency timelines. Orbis Clinical introduced an accomplished Labeling expert who quickly organized the project and ultimately developed/delivered a high-quality label.

Orbis Clinical Case Studies

Client in need of a Safety Physician Team to address on-going post marketed reporting requirements.

Client: Major Pharmaceutical Company Location: Mid West

Services Provided:

Orbis Clinical created a virtual bench of experienced, qualified, safety physicians to address the client’s reporting requirements. These physicians were introduced on short notice to assist the client team with sudden spikes in workload. As a result, our client has continued to meet all deadlines for various regulatory response and reporting requirements.

Orbis Clinical Case Studies

MHRA request of European risk re-evaluation update for an established product.

Article 31 Risk Re-Evaluation Engagement

Client: Global Biopharmaceutical Company Location: Philadelphia PA Solution Provided: Retained by client to respond to an Article 31 risk re-evaluation of major revenue

producing product. Provided experienced team of 5 physicians to spearhead aggregate review and analysis while providing documentation of findings along with presentation to CSB. Project completed successfully within extremely short deliverable timelines.

Orbis Clinical Case Studies

Company wide Labeling initiative involving updates for 7 products across all therapeutic areas.

Reference Safety Information Update Engagement

Client: Global Biopharmaceutical Company Location: Philadelphia PA Solution Provided: Retained by client to update Company Core Data Sheets for company wide US and

European Labeling initiative. Reference Safety Information Project employed 10 physicians with a Team Lead involving 7 products. Initiative touched on all products and therapeutic areas encompassing all terms. Update of Legacy information from COSTART to MedDRA as well as update of all MedDRA terms to most recent release. Project deliverables included medical adjudication of individual cases, literature searches, writing of findings in aggregate with individual presentations to CSB. Project completed successfully within extremely short deliverable timelines.