capabilities in phase 1 - aaipharma.de 2016/nuvisan clinical...gcp good clinical practice glp good...

[email protected] www.nuvisan.com

Capabilitiesin Phase 1

NUVISANPharma Services

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CLINICAL SERVICES

Capabilities in Phase 1Your highly recognized service provider

CLINICAL SERVICES

CONTENT1 NUVISAN PHARMA SERVICES Page 41.1 Contact Information Page 51.2 Clinical Services Page 61.2.1 The Clinical Pharmacology Unit (CPU) Page 61.2.2 Additional services Page 71.3 Clinical I Experience Page 81.3.1 Clinical Studies Page 81.3.2 Personnel Page 91.4 Equipment and Instruments Page 11

2 CONDUCT OF CLINICAL STUDIES Page 112.1 Regulatory Approval Page 112.1.1 Regulatory Bodies Page 112.1.2 Approval Process Page 122.1.3 Combined Study Protocols Page 122.2 Safety Monitoring Page 132.3 Independent Monitoring Page 142.4 Subject Insurance Page 15

3 RECRUITMENT Page 15

4 ADDITIONAL SERVICES Page 164.1 Clinical Trial Supplies Division Page 164.2 Pharmaceutical Analytics Page 174.3 Bioanalytical Laboratory Page 174.4 Biostatistics/Pharmacokinetics Page 184.5 Data Management Page 194.6 Medical Writing 0

5 OTHER INFORMATION Page 215.1 Clinical Quality Systems Page 215.2 Inspections and Approvals Page 215.3 Computer Systems Page 215.3.1 Hardware Page 215.3.2 Software Page 225.3.3 Electronic Exchange of Confidential Information Page 225.3.4 Inspection List Page 23

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Our experienced medical staff ensurestop quality conduct and standardized

interpretation of Phase I studies in ourclinical research unit.

ACRONYM LEGENDBfArM Bundesinstitut für Arzneimittel und Medizinprodukte CA Competent Authority CDISC Clinical Data Interchange Standards Consortium CDM Clinical Data ManagementCPU Clinical Pharmacology Unit CPU Clinical Pharmacology Unit CTA Clinical Trial Assistants CTS Clinical Trial SuppliesDMPK Drug Metabolism and Pharmacokinetics EC Ethics Committee ECG Electrocardiogram FACS Fluorescence Activated Cell Sorting GCMS Gas Chromatography Mass Spectrometry GCP Good Clinical Practice GLP Good Laboratory PracticeGMP Good Manufacturing PracticeICP Inductively Coupled Plasma IMP Investigational Medicinal Product IMPD Investigational Medicinal Product Dossier MAD Multiple Ascending Dose MD Medical DoctorPEI Paul-Ehrlich-Institut PK PharmacokineticsSAD Single Ascending Dose SmPC Summary of Product SOP Standard Operating Procedures


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CLINICAL SERVICES

1 NUVISAN PHARMA SERVICESNuvisan Pharma Services (Nuvisan) is a fully integrated Contract Research Organisation

(CRO) and pharmaceutical services provider with a 35-year track record serving clients

needs in clinical development. Nuvisan started operation as a privately owned contract

research institute LAB in 1979 and has been performing clinical pharmacological and

pharmacokinetic studies since that time, driven by Experience, Commitment and Techno-

logy under one roof.

Headquartered in Neu-Ulm, Germany, the NUVISAN Group has more

than 300 employees and features three strategic business units:


2 CONTACT INfORMATIONNUVISAN Headquarter Neu-Ulm / Germany

Located in idyllic Bavaria in the town of Neu-Ulm on the banks of the Danube river

together with Ulm, the birthplace of Albert Einstein.

NUVISAN GmbH

Wegenerstrasse 13

D-89231 Neu-Ulm

NUVISAN Analytical Services GmbH

Im Wirrigen 25

D-45731 Waltrop

Nuvisan Pharma Grafing GmbH

Am Feld 32

D-85567 Grafing


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Phone: +49 731 9840 0

Fax: +49 731 9840 280

Phone: +49 2309 9376 0

Fax: +49 2309 9376 420

Phone: +49 8092 7008 0

Fax: +49 80832 7008 99


Sylvie BruchmannVice President Clinical Business DevelopmentPhone: +49 172 7110 592Email: [email protected]

Dwight StiffVice President Business DevelopmentPhone: +49 731 9840 366Email: [email protected]

CONTACT BUSINESS DEVELOPMENT

CLINICAL SERVICES

1.2 CLINICAL SERVICESNuvisan’s Clinical Services Division was established in 1981. Now hoasting a fully equipped

Clinical Pharmacology Unit (CPU), Nuvisan’s Clinical team offers full service capabilities

combined with over 3 decades of medical and development expertise.

1.2.1 THE CLINICAL PHARMACOLOGY UNITThe CPU comprises overnight facilities with full catering services including special diets,

with separate functional rooms for drug administration, blood sampling, sample work up,

Electrocardiograph (ECG) recording, interim storage of study medication as well as an

“intensive assessment station” with 3/5-lead ECG telemetry equipment for 24 subjects and

a screening examination unit. An in-house clinical laboratory unit is available providing the

option of approximately 200 established clinical laboratory parameters. An emergency

trolley including defibrillator is available in the intensive assessment station. Transportable

emergency equipment is available on the other floors. All equipment that might be required

for measurement of vital signs, ECG recording, parenteral drug administration etc. is

available and maintained according to German regulations (“Medizinprodukte Gesetz”)

and applicable European guidelines.

Characteristics of the Clinical Pharmacology unit• 100 beds for overnight hospitalization

• Intensive assessment station with 40 beds

• Total of 4.000 m² / 43.000 ft² space

• Five procedure rooms for interventions and investigations - that can be equipped

according to study specific requirements such as


- Neurology - Gynaecology

- Ophthalmology - Pulmonology

- Cardiovascular - etc.

• Recreation area & home cinemas

• Special WLAN coverage for the volunteers

• On-site catering for standard & special diets

• On-site clinical laboratory

Having a history of 35 years in clinical research operations with more than 1,400 studies

performed is a testament to the expertise and experience in early clinical research. NUVISAN

can deliver with it’s first class clinical pharmacology services. Our passion is to support the

sponsor in bringing safe and effective pharmaceutical products to market quickly.

1.2.2 ADDITIONAL SERVICES In addition to Clinical Trial expertise, we provide services in Pharmaceutical Analytics,

Formulation Development, Clinical Trial Supplies & Biometrics - Biostatistics, PK & PD

analysis, Data Management, Clinical Monitoring as well as Regulatory Affairs Services.

Furthermore, we have one of the leading European Analytical Research Centers in house

which concentrates on the analysis of biological samples from a complete range of clinical

pharmacology studies using state of the art liquid chromatography mass spectrometry

(LC-MS/MS), gas chromatography mass spectrometry (GC-MS), Inductively Coupled Plasma

(ICP) mass spectrometry (ICP-MS) and immunoassay as well as Fluorescence Activated cell

Sorting (FACS) techniques. More than 300 validated standard methods are available to the

clients while other proprietary methodology has been developed jointly with pharmaceutical

manufacturers. The Drug Metabolism and Pharmacokinetics (DMPK) unit (Preclinical

Services) also provides scientific support to our clinical development team.

Services to support the conduct of the studies• Recruitment team

• On-site clinical safety laboratory

• On-site bioanalytical laboratory

• On-site pharmacy


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CLINICAL SERVICES

Additional supporting services include• Medical & Regulatory Affairs Consultancy

• Medical writing

• Clinical Trial Supplies

• Project Management

• Biostatistics / Pharmacokinetics (PK)

• Clinical Monitoring

• Data Management

1.3 CLINICAL EXPERIENCEOur clinical services include the following study types, and can be performed in healthy

volunteers and in special patient populations:

• First in man SAD/MAD & integrated packages • Studies with Biologicals/Biosimilars

• Drug / Drug interaction studies • TQT Studies

• Studies in special patient populations • BA / BE studies

• Food effect studies • Age and gender studies

• Biomarker studies, e.g. immunological • Vaccination studies

parameters with on-site analysis capabilities • Proof of Concept studies

1.3.1 CLINICAL STUDIESNuvisan Clinical Services has 35 years of experience in the planning and conduct

of Phase I studies.


Design Trials in Phase I (since 1981) .

Single Dose > 1100 .

Multiple Dose 300 .Total > 1.400 .

1.3.2 PERSONNELNuvisan’s team members, responsible for the conduct of all studies at our Phase I facility,

are medically trained physicians, research nurses and laboratory technicians, working in

cooperation with non-medical team members.

Our physicians take on medical responsibility for the studies, in the role of the investigator

or principal investigator, and are supported by study nurses experienced in the preparation

and conduct of clinical trials, the majority of them for many years. They regularly undergo

trainings in Standard Operating Procedures (SOP), Good Clinical Practice (GCP) guidelines,

newly implemented legislation etc. They are practically and theoretically trained in the

treatment of medical emergencies. We have our own in-house gynecologist for women´s

health studies. Specialists in a specific field e.g. neurology, ophthalmology or anesthesiology,

can join the group of investigators if this is considered necessary for the study. Our strength

is based on the high qualifications of the Investigators and Team members.

Nuvisan’s Clinical Services has over 130 employees, as detailed below:


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Design Trials in Phase I (since 2000) .First In Man 26 .Drug-Drug-Interaction 24 .Food Effect 10 .Gynecology 28 .Cardiology 42 .Immunology 27 .CNS 65 .Respiratory 12 .Endocrinology 23 .Urology 12 .Total > 269 .

Clinical Staff (Headcount)

Physicans / Investigators 7 .

Study Coordinator 11 .

Clinical Safety Laboratory 7 .

Pharmacy Clinical Trial Supplies 24 .

Project Managers 7 .

Monitors 3 .

CLINICAL SERVICES

Personnel and respective functions according to German Drug Act (Arzneimittelgesetz)


Function Responsible Person

Principal Investigator Dr. med. Horst Jürgen Heuer

Principal Investigator Michael Lissy, MD

Principal Investigator Manuela Koch, MD

Principal Investigator Tamara Richter, MD

Principal Investigator Dr. med. Beate Klaus

Principal Investigator Denis Strugala

Gynecologist Christoph Kirchmayer

Head of Quality Control + QP Michael Frey

Head of Production Maria Sattler

Clinical Trial Assistants (CTA) 4 .

Data Science / Pharmacokinetics 9 .

Data Management 5 .

Qualified Person 2 .

Administration Managers 2 .

Recruitment Team 5 .

Kitchen 7 .

Time-flexible GCP trained staff 40 .

Overall Headcount 133 .

Management

1.4 EQUIPMENT AND INSTRUMENTSOur Phase I unit is equipped with the following systems• 4 x ECG Systems

• 24 x Telemetry Electrocardiogram (ECG)

• 5 x SpO² Measurement System

• 1 x Ultracentrifuge

• 7 x Multi-Centrifuges

• 15 x Blood pressure monitors

• 1 x Spirometry measurement

• 13 x Injection pumps

The use of each piece of equipment is guided by an internal SOP, describing calibration

requirements in detail.

2 CONDUCT Of CLINICAL STUDIES

2.1 REGULATORY APPROVAL

2.1.1 REGULATORY BODIESWith our Clinical Phamacology Unit (CPU) located in Neu-Ulm, Germany, studies conducted

by Nuvisan in our clinic are subject to regulatory approval by the German Competent

Authority Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), or by the Paul-


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Position / Job Title Name Qualification Experience

Vice President Clinical Services James Dickinson MSc Clinical Pharmacology 20 years

Chief Medical Officer Dr. Christian Reh Medical Doctor 26 years

Head Clinical Conduct Karlheinz Hebeler Paramedic 11 years

Lead Study Coordinator Petra Schuh Registered Nurse 18 years

RecruitmentManager

Sibyl Klotz-Vangerow Biologist 8 years

CLINICAL SERVICES

Ehrlich-Institut (PEI) for studies conducted with biological products. In our experience,

working with these agencies provides several benefits:

• BfArM and PEI are both considered to be opinion leading European regulatory agencies,

and have experts in all therapeutic fields.

• In our experience with Clinical Trial Applications (CTAs), both German agencies have

always been reliable, and have always met the timelines defined by German legislation

i.e. 30-day assessment time for substances of chemical origin).

• Both agencies are responsive; it is possible to contact the experts.

• Queries from the agencies have always been specific and based on scientific reasons.

• Both agencies offer Scientific Advice as a valuable instrument to optimise the

development program and to answer specific questions.

2.1.2 APPROVAL PROCESSAfter having submitted a clinical trial application to the ethics committee and competent

authority, both institutions have 30 days to assess the CTA with regards to content.

Following this assessment, regulatory bodies will either approve the trial without objections

or issue a deficiency letter describing objections to the study. The latter may require re-

submission of documents to clear the objections addressed by the CA/EC. Submissions to

CA may be done in parallel or sequentially.

2.1.3 COMBINED STUDY PROTOCOLSCombined protocols can be submitted in case of sequential studies such as Single Ascending

Dose (SAD) and Multiple Ascending Dose (MAD) studies, sometimes followed by a

complementary study e.g. a food effect study or a patient study. If the complexity of the

study allows, different scenarios are applicable:


2.2 SAfETY MONITORINGThe scope and extent of safety monitoring is determined by the expected effects and

adverse effects of the Investigational Medicinal Product (IMP), as well as the study type. In

every case, subjects will be under medical and paramedical supervision for several hours

after drug administration and will be questioned repeatedly regarding adverse events. The

procedures for detecting and documenting adverse events are guided by SOPs.

Additionally, if required, vital signs (blood pressure, pulse rate, respiratory rate) can be

measured and 12-lead ECGs recorded, according to Nuvisan SOPs. In first-in-man studies

or if the IMP may cause cardiac arrhythmias, telemetry is performed. Moreover, Holter

ECGs may be recorded before and at specified times after drug administration. Safety

monitoring also includes clinical laboratory tests which are performed in Nuvisan’s own

in-house clinical laboratory and promptly evaluated by a physician. If required, in addition

to a comprehensive screening examination which is performed in all subjects before they

are included into a study, physical examinations may be performed at specified study

times during the study and at study end. For First-in-Man studies (or as required) an

anaesthesiologist can be present.


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Single „umbrella“ protocolGain: 30 days

Single „development program“Gain: 14 days

SAD + MAD with one protocol

SAD + MAD with two different protocols, but considered as one development program

Only one submission (instead of two submissions)

to both BfArM and EC

Two submissions, but review time for the second study is only 14 days, for both

BfArM and EC

One development program

One protocol

One development program

Individual protocols

SAD MADSAD MAD

CLINICAL SERVICES

Medical Emergencies

Should we have a medical emergency, all medical staff are trained on our emergency

procedure SOP. The responsible physican would decide which target hospital the subject

will be admitted to according to the present medical case. In most cases these hospitals

would be the University Hospital Ulm, the German Army Hospital Ulm or the Donau-Clinic

Neu-Ulm. The closest hospital is just 5 minutes away.

2.3 INDEPENDENT MONITORINGNuvisan’s CPU operates in full compliance with ICH GCP and any applicable local & EU

regulatory requirements. Monitoring is conducted according to SOPs, ICH GCP and any

applicable regulatory requirements, and in accordance with the trial-specific monitoring

plan. A monitoring plan is developed by the Medical Writer in cooperation with the assigned

lead CRA, and is provided to the sponsor for review and approval. According to this

monitoring plan, site initiation visits, monitoring visits and close-out visits are scheduled

in cooperation with the project manager. Monitors retain their independence from the rest

of the clinical team with different IT access rights and separate reporting lines.

During the site initiation visit and during the close-out visit (and additionally as required)

a full Investigator File (IF) review and as required IMP accountability review will be performed

by the Monitor. The IF will be reviewed during monitoring visits as needed and/or requested

by the sponsor. IMP accountability will also be done as applicable during the course of the

trial, based on the nature and criticality of the investigational product and on whether such

services are specified in the contract. As required, another individual would be assigned as

an unblinded monitor to perform clinical supply monitoring.


During the monitoring visits, the focus lies on Source Data Verification against the Case

Report Form (CRF) . All observations are captured in a standardized monitoring visit report

and a corresponding follow-up letter that may be issued combining several days of

monitoring work for sake of efficiency in larger studies. Monitoring reports are delivered

directly to the sponsor and are not seen by the rest of the Nuvisan clinical team.

2.4 SUBJECT INSURANCEClinical trial insurance is a sponsor responsibility and is subject to local insurance

requirements. If this task is contractually delegated to Nuvisan, Nuvisan will contact

insurance brokers to apply for a subject insurance, present the proposals of the insurance

brokers to the sponsor and, on the basis of the sponsor's decision, will contract the subject

insurance coverage with a specific insurance company on behalf of the sponsor.

3 RECRUITMENTNuvisan has a dedicated team responsible for the recruitment of subjects, both healthy

volunteers and patients. The Recruitment Team comprises the following elements:

• Recruitment Manager

Responsible for the strategy formation and coordination of all advertisements.

• Study Information Centre

Consists of 4 employees, who are responsible for the telephone service, coordination of

appointments, subject database maintenance, screening activities and documentation.

• Call Centre

Retains a pool of 4 temporary employees, available for call centre activities at peak

periods. This can be extended up to a team of 20 if required.

To facilitate recruitment, the Recruitment Team develops advertising campaigns to increase

our database and tailored campaigns for recruiting special populations.


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CLINICAL SERVICES

• All study specific advertising campaigns are submitted to the EC for approval.

• All advertising campaigns can start after the EC approval. Recruited persons are required

to attend an Information Session and undergo screening; these procedures would only

start after the relevant protocol has received competent authority and EC approval.

• Nuvisan also has an EC approved generic screening protocol, allowing us to screen

volunteers on a non study-specific basis.

Recruitment methods

• Homepage

• Newsletter

• Flyer

• Local fairs (health & lifestyle)

• Free Web portals

• Web Adverts (google, facebook)

• Social communitiy blog (facebook, twitter, instagram)

4 ADDITIONAL SERVICES

4.1 CLINICAL TRIAL SUPPLIES DIVISIONOur CTS department can provide formulation development in support of clinical trials as

well as a full range of manufacturing, primary and secondary packaging, labeling (including

randomization) and distribution services in support of studies.


The CTS department is staffed by two Qualified Persons and therefore can offer the full

range of services (e.g. import, release, manufacturing site audits, etc.) that require this

high level of expertise.

4.2 PHARMACEUTICAL ANALYTICSWe offer complete stability testing programs, from developing a stability protocol to a final

custom report generation. Whether the scope is pilot-formulation, packaging changes, drug

development, registration, follow-up-stability or Clinical Trial Supplies (CTS), we will fulfill

the customers demands and quality standards.

In addition to complete studies, we can also perform any portion of a study, such as analytics

(method development/ validation etc.) and stability storage. Other stability study aspects

include photostability, in-use-stability and forced degradation studies.

Studies are performed in accordance with the most recent CHMP/CPMP/ICH-guidelines in

a GMP- & cGMP-environment, maintaining all confidential aspects of the project. All

procedures are described, conducted and documented in accordance with our SOPs. The

laboratory is GMP inspected and under control of the responsible German authority in

Munich.

The test facility is also GLP inspected. The GLP Certificate, Catagory 9, Analysis of

Formulations for Toxicological Studies, has been issued by the local state authority

(Bayrisches Landesamt für Gesundheit und Lebensmittelsicherheit).

4.3 BIOANALYTICAL LABORATORYBased at the same site in Neu-Ulm next to our Phase I clinical unit, Nuvisan’s Bioanalytical

Services has one of the largest bioanalytical laboratories in Europe, with over 60 qualified

scientists. At this facility we can conduct analysis of parent molecules or metabolites, and

endogenous compounds in biological matrices at all stages of product development. As

well as Phase I studies, we have the capacity to provide support for large Phase II – IV

studies (> 50,000 samples, > 3 years duration). Our bioanalytical laboratory is certified by

the FDA and ANVISA, and is GLP certified and GMP compliant.


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CLINICAL SERVICES

Assay Development and Validation

Based on the experience of more than 25 years working in the bioanalytical field, assay

development is carried out by well-trained staff in a timely manner, according to the current

guidelines of EMA and FDA.

4.4 DATA MANAGEMENTNuvisan has a long-established experience in data management with a team of highly

qualified professionals. The Clinical Data Management team follows best practices and

well-documented processes that will be tailored to your study. All data management

systems are compliant with 21 CFR Part 11.

Effective data collection and management for clinical trials is accomplished using Oracle

data management software (ClinTrial 4.7; Inform). This leading clinical database

management system is fully validated, meets ICH/GCP guidelines and is 21 CFR Part 11

compliant. Nuvisan’s team has used the Oracle software for more than 50% of our trials.

The Data Manager is the single point of contact and coordination for clinical data

management activities.

The Data Manager ensures:

• Proactive collaboration with the Project Manager, CRA, programmer, project

biostatistician, and medical writer as applicable to ensure that data management

needs are being met and that the deliverables are provided to the Sponsor according

to the mutually agreed timelines

• Participation in routine project teleconferences as well as face-to-face meetings,

if requested, with the Sponsor project team


• A lead role is taken in the development of a targeted data cleaning strategy

• Management of all data management project-level deliverables

• Supervision of all data management documentation and change control

• Successful vendor management, as required

• Processes are maintained consistently

• Provision of project status reports

4.5 BIOSTATISTICS / PHARMACOKINETICSNuvisan offers biometrical services for clinical Phase I to IV. These services can be provided

to the pharmaceutical industry as a part of a clinical study or as a stand-alone service.

Services available include

• Biometrical consulting (study design, development programs, regulatory consulting,

randomization, sample size calculation, planning of the statistical analysis)

• SAS®-programming, Version 9.4 or later

• Biometric services with respect to: Pharmacokinetics / Toxicokinetics (bioavailability,

bioequivalence, dose proportionality, drug interaction, food interaction, tolerability)

• Pharmacodynamics (including biomarkers)

• Biostatistical analysis

• Data migration / integration - Clinical Data Interchange Standards Consortium (CDISC)

• Integrated summary of safety and efficacy

• Writing of biometrical reports.


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CLINICAL SERVICES

The use of SOPs (NUVISAN or sponsor SOPs), consistent procedures and standard programs

ensures that the highest quality is maintained. Our biometricians advice is custom-tailored

at every key point from the earliest stages of clinical development planning to the final

presentation of data. We are able to provide expert guidance to optimize the statistical

design and analysis of studies in a broad spectrum of development phases.

Nuvisan’s core team of in-house experts have a strong background in planning, analyzing

and reporting of clinical studies according to the highest regulatory and scientific standards.

Experience in Biostatistics as well as Pharmacokinetics and Pharmacodynamics allows us

to evaluate data from pharmacokinetic and clinical pharmacology studies, ensuring a

seamless interface between pharmacokinetic and statistical analysis of bioanalytical data.

4.6 MEDICAL WRITINGNuvisan Pharma Services’ team of medical writers offer the full range of Medical Writing

services, either as part of a clinical study or as a stand-alone service. Services include

preparation of study protocols, clinical study reports, manuscripts for publication in

peer-reviewed journals, abstracts, posters for conferences, and regulatory documents

(Investigator Brochures, IMPD´s and CTD modules). Our Medical Writers work in close co-

operation with all relevant departments, e.g. Biostatistics and Regulatory.


5 OTHER INfORMATION

5.1 CLINICAL QUALITY SYSTEMS Nuvisan’s Quality Management (QM) department is responsible for the development,

establishment and maintenance of the electronic QM system. The QM document structure

is based on a 3-tier system with a quality manual at the top, followed by policies applicable

to all employees and finally role relevant SOP´s. The Quality Management department

consists of three audit groups (GCP, GLP, GMP) covering project and system audits.

5.2 INSPECTIONS AND APPROVALSAll of Nuvisan’s facilities are regularly inspected in accordance with all applicable local and

international guidelines. A table summarising inspections and approvals by any regulatory

authority in the last three years is presented below. Copies of certificates are available upon

request.

5.3 COMPUTER SYSTEMSNuvisan maintains long standing business relationships with World-Class vendors and

highly skilled Information Technology-Specialists to maintain a stable and safe working

environment throughout all departments and locations of the Nuvisan Group. SOPs are

used throughout Nuvisan to ensure that all aspects of Information Technology are carefully

regulated; as such, use of software is restricted to trained individuals, any changes to hard-

ware and software require approval from IT management, and no changes can be made

to validated systems without a properly documented assessment of the impact of changes

on the validation status.

5.3.1 HARDWAREAll Nuvisan hardware is obtained and configured according to SOPs. In general, workstations

used are standard industry computers; workstations attached to analytical instruments are

either delivered by the instrument vendor or are standard industry computers which comply

with the vendor’s hardware requirements.


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CLINICAL SERVICES

5.3.2 SOfTWAREA variety of standard and specialized software packages are used at Nuvisan, including

Clintrial 4.7, Empower v2 FR3, various analyst systems (Analyst v1.4.2 and v1.5.1, Analyst-

DataCheck v4, dbLabCal v3) and biostatistics packages (SAS 9.4 and WinNonlin 6.2),

CTS Label, and Randomizer.

5.3.3 ELECTRONIC EXCHANGE Of CONfIDENTIAL INfORMATIONFor the secure exchange of information we offer our customers easy to use and secure trans-

port mechanisms such as an SSH File Transfer Protocol (SFTP) Server and Encrypted Emails.

Our email-system supports all industry standard encryption techniques, ranging from fine

grained user-specific encryption to company-wide encryption.



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5.3.4 INSPECTION LIST

NUVISAN GmbHWegenerstrasse 1389231 Neu-Ulm[nbsp]Germany

Phone: +49 731 9840 0Fax: +49 731 9840 280

NUVISAN Analytical Services GmbHIm Wirrigen 2545731 WaltropGermany

Phone: +49 2309 9376 0Fax: +49 2309 9376 420

Nuvisan Pharma Grafing GmbHAm Feld 3285567 GrafingGermany

Phone: +49 8092 7008 0Fax: +49 80832 7008 99

Our resources become yours.Fully integrated Contract Research Organisation with over 35 years of serving the pharmaceutical industry.A leading CRO driven by Experience, Commitment, and Technology made in Germany.


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capabilities in phase 1 - aaipharma.de 2016/nuvisan clinical...gcp good clinical practice glp good...

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