The Company / Our Clients / Our People and Partners / Geographical Presence / Services and Experience / Clinical Operations / Paediatric Studies / Oncology Studies / Medical /Devices / Combination Products / Training Programmes / E-training / Quality Assurance / Quality Controlled Trial Management System (QCTMS)

GCP-Service International Ltd. & Co.KG

Anne-Conway-Str. 2 / 28359 Bremen / Germany / Phone +49 (0) 421 - 4 34 86 58 / Fax +49 (0) 421 - 4 34 86 59E-Mail info@gcp-service.com / www.gcp-service.com

GCP-ServiceYOUR CLINICAL TRIAL SERVICE PROVIDER

GCP-Service GCP-Service

Geographical PresenceFigure 1 shows the geographical areas in which GCP-Service

has already provided Clinical Operations and Quality Assurance

services: Austria, Belgium, Finland, France, Germany, Hungary,

Italy, Netherlands, Norway, Poland, Serbia, Sweden, Switzerland,

UK, USA

The CompanyWith the national headquarters in Bremen (Germany),

Warsaw (Poland) and Kaprijke (Belgium), GCP-Service is

a 100% privately owned full-service CRO. Since its founda-

tion in 2004, the company has grown to a size that enables

it to deliver all required services, while maintaining high

fl exibility and minimising overhead costs. This provides

GCP-Service with the scope to conduct a wide variety of

clinical studies, meeting the individual and specifi c needs

of our clients.

Our ClientsA repeat business rate of 100% demonstrates the extre-

mely high satisfaction level clients of GCP-Service have.

We remain focused on the delivery of quality clinical

research services to the pharmaceutical, biotechnology

and medical device industries. GCP-Service enjoys a wide

spread of business, with no individual client contributing

more than 30% of our turnover.

Our People and PartnersThe efforts and energy GCP-Service has invested in employees

and partners to achieve the excellent quality which characte-

rises the services we offer is refl ected in the commitment and

loyalty of our employees and partners.

More than 80% of the GCP-Service team have an academic

education which, together with intensive ongoing training, ac-

cumulating experience, and a unique internal incentive system

make the complete GCP-Service team a reliable and highly

motivated service provider.

Integrating the support of reliable strategic partnerships with

individuals and companies which implement similar quality

policies, GCP-Service is in a position to provide high standards

of services throughout Europe and the USA.

GCP-Service Products GCP-Service

Table 1 GCP-Service clinical study experience up to 2010

Phase I Phase II Phase III Phase IV NIS Medical device trials

Studies performed

8 8 19 2 5 12

Patients enrolled

361 1064 15049 1600 3400 2953

Study sites 56 111 750 45 650 125

Table 2 Medical Experience of GCP-Service

Aesthetic Medicine Neurosurgery

Allergy Obesity

Burn Wounds Oncology

Cardiovascular Diseases Ophthalmology

Dermatology Orthopaedics

Gastro-Intestinal Diseases Paediatrics

Infectious Diseases Pneumology

Metabolism Surgery

Nephrology Urology

Neurology Vaccination

Clinical OperationsAs a full-service CRO, GCP-Service is aware of the importance

of being able to service a wide range of clinical phases and

types of clinical studies. While Phase I studies provide impor-

tant initial information for planning strategies within a drug

development program, post-marketing studies are important in

that they deliver real-life data on study populations which were

often excluded from the clinical studies Figure 2.

Regardless of whether you want to investigate a pharmaceuti-

cal product, a medical device or combination product, your cli-

nical study and your project are in good hands at GCP-Service.

This multinational expertise, derived from experience in a mul-

tiple of clinical studies, is an asset for clients needing support

during the development process of their medical product. Table

1 shows the experience of GCP-Service in different study ty-

pes, while Table 2 shows the indications in which these studies

have been performed.

Services and ExperienceGCP-Service considers the quality of our service the most

valuable asset of our business relationship with our clients.

Our mission is to cultivate long-term partnerships which

increase both our productivity and cost-effi ciency for our

clients. This strategy, combined with constrained overheads,

enable us to deliver extremely high quality at extremely

competitive prices through economy of scale.

GCP-Service provides expertise in the following areas:

• Clinical Monitoring

• Project Management

• Auditing

- according to ICH GCP

- systems

- projects

- ISO 14155

• Data Management

• Biostatistics

• Medical Writing

• Translation

• Importation, Packaging, Storage and

Distribution of Investigational Products

• Central Laboratory

• Electronic Data Capture (EDC)

Figur 2 Drug development phases covered by GCP-Service

Paediatric StudiesChildren are not »little adults«, especially from the perspec-

tive of developmental physiology. As numerous examples

have demonstrated, it is often not possible to simply adjust

the dosage of drugs that are successfully used on adults.

Finally, it has been recognised that only by conducting

targeted clinical studies on minors will it be possible to

conclusively remedy the problem of children as »therapeutic

orphans«.

Since 2008, new rules are applicable for clinical studies

with paediatric study populations. Authorities have recognis-

ed that the fact that more than 50% of all used pharmaceu-

tical products are licensed both for children and adolescents

creates a situation which represents an unacceptable risk

for this patient population. More clinical studies with minors

are needed to get data and pharmaceuticals licensed for

this population as well. However, the regulations and requi-

rements are very strict for studies where infants are part of

the patient group.

GCP-Service conducts clinical studies with minors. The

company has conducted studies with up to 5500 children.

That was only possible due to the enormous pool of paedi-

atric study centres and well trained staff GCP-Service has.

Professional trainers provided more than 100 paediatricians

and study nurses with certifi ed training in clinical research,

ICH GCP and national regulations to ensure the welfare and

rights of this study population while providing reliable study

data.

GCP-Service Products

GCP-Service Products

Oncology StudiesCancer affects us all, whether we have it, care about someone

who does, or worry about getting it in future. Oncology is one

of the most challenging fields in clinical research. During re-

cent years, few effective treatments have been developed and

licensed to treat certain cancers. Some companies have very

promising drugs in the pipeline. However, the mortality rate

of cancer is far too high and much more clinical research is

needed to decrease this rate significantly. Oncological studies

have special rules. They are usually longer and more complex

than those targeting other diseases. Due to the complexity

and variability of the different oncological indications, GCP-

Service has extensive experience with various oncological

studies. We have performed phase I, II, III and non-interventi-

on clinical studies for the following indications:

• Bladder Cancer

• Breast Cancer

• Cervix Cancer

• Colon Cancer

• Gastric Cancer

• Head Cancer

• Leukemia

• Lung Cancer

• Malignant Lymphoma

• Neck Cancer

• Pancreatic Cancer

Since the beginning of 2009, GCP-Service also offers

oncology SMO (Study Management Organisation) services.

The combination of medical and scientifi c competence of

GCP-Service Oncology optimises the return on your clinical

research investments. We treat nearly all oncological indica-

tions on an outpatient basis. With a huge geographical service

area through Northern Germany, GCP-Service can achieve

your recruitment goals and provide you with high quality and

reliable data.

Medical Devices/ Combination ProductsChallenging tasks require exceptional solutions. Many years

of experience and expertise enable GCP-Service to offer

a well-trained expert team providing clinical research and

regulatory services for all kinds of medical devices and drug-

device combination products. GCP-Service is one of the few

CROs worldwide offering services for medical device studies.

With the amendment to the EU Medical Device Directive

MDD 93/42/EEC, the requirements for performing clinical

studies for supporting data have been implemented. If you

need clinical data for your product, you need an experienced

partner. GCP-Service offers services regardless of whether a

CE marking is intended or is already placed, whether a class I

or a class III device, whether in Europe or in the rest of the

world.

The development of combination products, utilising the physi-

cal benefi ts of medical devices together with the pharmaceu-

tical effects of drugs, will be one of the great challenges of

the current century. However, medical devices and phar-

maceuticals are from extremely different worlds in terms of

history, philosophy and regulations. To successfully combine

these, you have to draw on expertise from both worlds.

GCP-Service offers this: if you need support to develop your

product, please contact us. We are here to support you!

We have conducted studies with medical devices or combi-

nation products in following indications:

• Bladder Cancer

• Cervical Cancer

• Cervical Degenerative Disc Disease

• Colon Cancer

• Cruciate ligament rupture

• Diabetes Mellitus

• Geographic Atrophy

• Mitral Valve Regurgitation

• Primary Resurfacing Arthroplasty

• Retinitis Pigmentosa

• Shoulder Hemi Arthroplasty

• Thoracic Adolescent Idiopathic Scoliosis

• Ulcerative Colitis

Specialised Services and Systems Specialised Services and Systems

GCP-Service Products GCP-Service Products

E-trainingEqually important to training itself, is the evaluation of how successful

training activities are and where further training activities are needed.

Hence, GCP Service has developed a web-based e-training platform

for clinical research which can also be accessed by external persons

or groups in order to access a structured success-controlled training

system. With our training platform, trainees can receive training pre-

sentations and reference documents (e.g. most current regulations),

ending with training tests drawing randomly from a pool of more than

1000 questions related to the pre-selected training modules.

Trainees can select the following training modules:

• ICH GCP

• German drug law

• German medical device law

• ISO14155

• EU regulations

GCP-Service is also able to adapt the e-training platform according to

your needs, for example modules and questionnaires regarding your

SOPs can be produced, while keeping company-related information

100% confi dential.

Advantages of e-training are:

• Lower costs

• No additional travel costs

• Less time-intensive

• Time fl exibility

• Good learning effect

• Systematic identifi cation of training needs

• Measurement of training success

• Excellent documentation of training process

• Individual training adaptation

Training ProgrammesMotivated by the mission to provide high-quality services,

GCP-Service does not spare efforts or money to train our

own staff on regulations, standards and medical topics.

Based on our competence, GCP-Service became one of

the most active independent continuing medical education

(CME) providers that develop fair and balanced educational

programs for physicians, study nurses and industry. In

2009, GCP-Service provided approx. 300 investigators and

study nurses with certifi ed training.

Our investigator training program covers:

• Development of pharmaceutical products/

medical devices

• Basics of biometry, sample size calculation,

study designs

• Declaration of Helsinki

• ICH GCP

• Safety in clinical studies

• National regulations

• Audits and inspections

Our industry training program covers, for example:

• Effective clinical monitoring

• Use of e-CRFs

• Effective Project Management

• Quality assurance in clinical research:

QA versus QC

• Development of medical devices:

ISO 14155 versus GCP

The evaluation of our training sessions has shown that 95%

of the attendees rate our training programmes as “good” or

“excellent”. 87% praised the way the topics are presented

as excellent, and 89% liked the practical examples during

the training sessions.

Specialised Services and Systems Specialised Services and Systems

Quality Assurance

Project Management

Management Summary

Report Risk Evaluate Risk Generate Alerts

GCP-Service Products GCP-Service Products

QCTMSCurrently available CTMS tools have been developed predomi-

nantly to provide Project Managers with information required to

monitor the study status and plan further progress. GCP-Service

has developed a Quality Controlled Trial Management System

(QCTMS), which offers much more than other systems. QCTMS

is provided as an effective risk management tool in accordance

with ICH Q9 to identify and evaluate risks before problems occur.

QCTMS is a fl exible system which can be adapted according

to each clinical study, sponsor or SOP. Individual levels of

risk-factors can be specifi ed to initiate preventive actions, or as

an audit trigger to initiate corrective and preventive actions at

the fi rst sign of them developing. Typical parameters such as

informed consent process, SAE reporting timelines, recruitment

rates, query rates, number of protocol deviations, monitoring

frequency and many additional factors can be used to evaluate

Quality AssuranceGCP-Service performs project audits for you in order to

review the quality of the study performance within mono

and multi-centre studies. This service includes the review

of study compliance in terms of:

• Ethical norms

• Laws (physicians law, drug law)

• Regulations

• ICH GCP

• ISO 14155 Parts 1 and 2

• Contractual agreements

Additionally, GCP-Service offers independent system audits

at your selected CRO. This audit includes a comprehensive

review of key documents such as SOPs, training documents

and other documents relevant for the quality of implemen-

ted systems.

Generally the purpose of audits conducted by GCP-Service

is to improve the quality of clinical studies, independent

of the audit location. If necessary, investigator staff may

be provided with further training on ICH GCP, drug law and

regulations in a constructive and mutually benefi cial way.

The QA managers of GCP-Service have more than 13 years

of clinical research experience. They can support you with

risk management in your company, and we can help to

develop effi cient systems capable of reducing risk and

enhancing in-house quality.

Try UsOne of our secrets to success is our strategy of combining low costs with high quality and expertise.

If you need further information, please call us or visit our homepage under www.gcp-service.com

We look forward to being of service to you!

the risk to data quality, or risks for study subjects. Different

risk levels trigger automatic alerts to your Project Manage-

ment and/or Quality Assurance department

The use of QCTMS not only effectively improves quality but

also saves money by saving man-power. The quality control

process within a clinical study is an integral responsibility

of the Project Management. Unfortunately, this process is

often not carried out as intensively as required due to time

pressures, lack of recourses and other priorities. Audits, for

the most part, identify quality issues when it is too late to

take preventive action. QCTMS is a fl exible online tool which

takes over the quality control and reports risks according to

the needs of your Project Manager who can then focus on

the initiation of preventive actions.

Figure 4 Process of risk reporting, risk evaluation and risk alerting by QCTMS

Specialised Services and Systems Specialised Services and Systems

Figure 3 Risk Management via QCTMS according to ICH Q9