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- 1. GCP-Service YOUR CLINICAL TRIAL SERVICE PROVIDER 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)
- 2. GCP-Service GCP-Service The Company Our People and Geographical Presence With the national headquarters in Bremen (Germany) and Partners Figure 1 shows the geographical areas in which GCP-Service Kaprijke (Belgium), GCP-Service is a 100% privately owned has already provided Clinical Operations and Quality Assurance The efforts and energy GCP-Service has invested in employees full-service CRO. Since its foundation in 2004, the company services: Austria, Belgium, Finland, France, Germany, Hungary, and partners to achieve the excellent quality which characte- has grown to a size that enables it to deliver all required Italy, Netherlands, Norway, Poland, Serbia, Sweden, Switzerland, rises the services we offer is reflected in the commitment and services, while maintaining high flexibility and minimising UK, USA loyalty of our employees and partners. overhead costs. This provides GCP-Service with the scope More than 80% of the GCP-Service team have an academic to conduct a wide variety of clinical studies, meeting the education which, together with intensive ongoing training, ac- individual and specific needs of our clients. cumulating experience, and a unique internal incentive system make the complete GCP-Service team a reliable and highly Our Clients motivated service provider. Integrating the support of reliable strategic partnerships with A repeat business rate of 100% demonstrates the extre- individuals and companies which implement similar quality mely high satisfaction level clients of GCP-Service have. We policies, GCP-Service is in a position to provide high standards remain focused on the delivery of quality clinical research of services throughout Europe and the USA. 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.
- 3. GCP-Service GCP-Service Products Services and Clinical Operations Experience As a full-service CRO, GCP-Service is aware of the importance of being able to service a wide range of clinical phases and GCP-Service considers the quality of our service the most types of clinical studies. While Phase I studies provide impor- valuable asset of our business relationship with our clients. tant initial information for planning strategies within a drug Our mission is to cultivate long-term partnerships which development program, post-marketing studies are important in increase both our productivity and cost-efficiency for our that they deliver real-life data on study populations which were clients. This strategy, combined with constrained overheads, often excluded from the clinical studies Figure 2. enable us to deliver extremely high quality at extremely competitive prices through economy of scale. Regardless of whether you want to investigate a pharmaceuti- GCP-Service provides expertise in the following areas: cal product, a medical device or combination product, your cli- • Clinical Monitoring nical study and your project are in good hands at GCP-Service. • Project Management • Auditing This multinational expertise, derived from experience in a mul- - according to ICH GCP tiple of clinical studies, is an asset for clients needing support - systems during the development process of their medical product. Table - projects 1 shows the experience of GCP-Service in different study ty- - ISO 14155 pes, while Table 2 shows the indications in which these studies • Data Management have been performed. • Biostatistics • Medical Writing • Translation • Importation, Packaging, Storage and Distribution of Investigational Products • Central Laboratory • Electronic Data Capture (EDC) Table 1 GCP-Service clinical study experience up to 2010 Phase I Phase II Phase III Phase IV NIS Medical device trials Studies 8 8 19 2 5 12 performed Patients 361 1064 15049 1600 3400 2953 enrolled 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 Figur 2 Drug development phases covered by GCP-Service Neurology Vaccination
- 4. Specialised Services and Systems Specialised Services and Systems GCP-Service Products GCP-Service Products Paediatric Studies Oncology Studies Medical Devices/ Children are not »little adults«, especially from the perspec- Cancer affects us all, whether we have it, care about someone Combination tive of developmental physiology. As numerous examples have demonstrated, it is often not possible to simply adjust who does, or worry about getting it in future. Oncology is one of the most challenging fields in clinical research. During re- Products the dosage of drugs that are successfully used on adults. cent years, few effective treatments have been developed and Challenging tasks require exceptional solutions. Many years Finally, it has been recognised that only by conducting licensed to treat certain cancers. Some companies have very of experience and expertise enable GCP-Service to offer targeted clinical studies on minors will it be possible to promising drugs in the pipeline. However, the mortality rate a well-trained expert team providing clinical research and conclusively remedy the problem of children as »therapeutic of cancer is far too high and much more clinical research is regulatory services for all kinds of medical devices and drug- orphans«. needed to decrease this rate significantly. Oncological studies device combination products. GCP-Service is one of the few have special rules. They are usually longer and more complex CROs worldwide offering services for medical device studies. Since 2008, new rules are applicable for clinical studies than those targeting other diseases. Due to the complexity with paediatric study populations. Authorities have recognis- and variability of the different oncological indications, GCP- With the amendment to the EU Medical Device Directive ed that the fact that more than 50% of all used pharmaceu- Service has extensive experience with various oncological MDD 93/42/EEC, the requirements for performing clinical tical products are licensed both for children and adolescents studies. We have performed phase I, II, III and non-interventi- studies for supporting data have been implemented. If you creates a situation which represents an unacceptable risk on clinical studies for the following indications: need clinical data for your product, you need an experienced for this patient population. More clinical studies with minors • Bladder Cancer partner. GCP-Service offers services regardless of whether a are needed to get data and pharmaceuticals licensed for • Breast Cancer CE marking is intended or is already placed, whether a class I this population as well. However, the regulations and requi- • Cervix Cancer or a class III device, whether in Europe or in the rest of the rements are very strict for studies where infants are part of • Colon Cancer world. the patient group. • Gastric Cancer • Head Cancer The development of combination products, utilising the physi- GCP-Service conducts clinical studies with minors. The • Leukaemia cal benefits of medical devices together with the pharmaceu- company has conducted studies with up to 5500 children. • Lung Cancer tical effects of drugs, will be one of the great challenges of That was only possible due to the enormous pool of paedi- • Malignant Lymphoma the current century. However, medical devices and phar- We have conducted studies with medical devices or combi- atric study centres and well trained staff GCP-Service has. • Neck Cancer maceuticals are from extremely different worlds in terms of nation products in following indications: Professional trainers provided more than 100 paediatricians • Pancreatic Cancer history, philosophy and regulations. To successfully combine • Bladder Cancer and study nurses with certified training in clinical research, these, you have to draw on expertise from both worlds. • Cervical Cancer ICH GCP and national regulations to ensure the welfare and Since the beginning of 2009, GCP-Service also offers GCP-Service offers this: if you need support to develop your • Cervical Degenerative Disc Disease rights of this study population while providing reliable study oncology SMO (Study Management Organisation) services. product, please contact us. We are here to support you! • Colon Cancer data. The combination of medical and scientific competence of • Cruciate ligament rupture GCP-Service Oncology optimises the return on your clinical • Diabetes Mellitus research investments. We treat nearly all oncological indica- • Geographic Atrophy tions on an outpatient basis. With a huge geographical service • Mitral Valve Regurgitation area through Northern Germany, GCP-Service can achieve • Primary Resurfacing Arthroplasty your recruitment goals and provide you with high quality and • Retinitis Pigmentosa reliable data. • Shoulder Hemi Arthroplasty • Thoracic Adolescent Idiopathic Scoliosis • Ulcerative Colitis
- 5. Specialised Services and Systems Specialised Services and Systems GCP-Service Products GCP-Service Products Training Programmes E-training Motivated by the mission to provide high-quality services, The evaluation of our training sessions has shown that 95% Equally important to training itself, is the evaluation of how successful GCP-Service does not spare efforts or money to train our of the attendees rate our training programmes as “good” or training activities are and where further training activities are needed. own staff on regulations, standards and medical topics. “excellent”. 87% praised the way the topics are presented Hence, GCP Service has developed a web-based e-training platform Based on our competence, GCP-Service became one of as excellent, and 89% liked the practical examples during for clinical research which can also be accessed by external persons the most active independent continuing medical education the training sessions. or groups in order to access a structured success-controlled training (CME) providers that develop fair and balanced educational system. With our training platform, trainees can receive training pre- programs for physicians, study nurses and industry. In sentations and reference documents (e.g. most current regulations), 2009, GCP-Service provided approx. 300 investigators and ending with training tests drawing randomly from a pool of more than study nurses with certified training. 1000 questions related to the pre-selected training modules. Trainees can select the following training modules: Our investigator training program covers: • ICH GCP • Development of pharmaceutical products/ • German drug law medical devices • German medical device law • Basics of biometry, sample size calculation, • ISO14155 study designs • EU regulations • Declaration of Helsinki • ICH GCP GCP-Service is also able to adapt the e-training platform according to • Safety in clinical studies your needs, for example modules and questionnaires regarding your • National regulations SOPs can be produced, while keeping company-related information • Audits and inspections 100% confidential. Our industry training program covers, for example: Advantages of e-training are: • Effective clinical monitoring • Lower costs • Use of e-CRFs • No additional travel costs • Effective Project Management • Less time-intensive • Quality assurance in clinical research: • Time flexibility QA versus QC • Good learning effect • Development of medical devices: • Systematic identification of training needs ISO 14155 versus GCP • Measurement of training success • Excellent documentation of training process • Individual training adaptation
- 6. Specialised Services and Systems Specialised Services and Systems GCP-Service Products GCP-Service Products Quality Assurance QCTMS Currently available CTMS tools have been developed predomi- the risk to data quality, or risks for study subjects. Different GCP-Service performs project audits for you in order to nantly to provide Project Managers with information required to risk levels trigger automatic alerts to your Project Manage- review the quality of the study performance within mono monitor the study status and plan further progress. GCP-Service ment and/or Quality Assurance department and multi-centre studies. This service includes the review has developed a Quality Controlled Trial Management System of study compliance in terms of: (QCTMS), which offers much more than other systems. QCTMS The use of QCTMS not only effectively improves quality but • Ethical norms is provided as an effective risk management tool in accordance also saves money by saving man-power. The quality control • Laws (physicians law, drug law) with ICH Q9 to identify and evaluate risks before they occur process within a clinical study is an integral responsibility • Regulations QCTMS is a flexible system which can be adapted according of the Project Management. Unfortunately, this process is • ICH GCP to each clinical study, sponsor or SOP. Individual levels of often not carried out as intensively as required due to time • ISO 14155 Parts 1 and 2 risk-factors can be specified to initiate preventive actions, or as pressures, lack of recourses and other priorities. Audits, for • Contractual agreements an audit trigger to initiate corrective and preventive actions at the most part, identify quality issues when it is too late to the first sign of them developing. Typical parameters such as take preventive action. QCTMS is a flexible online tool which Additionally, GCP-Service offers independent system audits informed consent process, SAE reporting timelines, recruitment takes over the quality control and reports risks according to at your selected CRO. This audit includes a comprehensive rates, query rates, number of protocol deviations, monitoring the needs of your Project Manager who can then focus on review of key documents such as SOPs, training documents frequency and many additional factors can be used to evaluate the initiation of preventive actions. 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 Management Summary be provided with further training on ICH GCP, drug law and regulations in a constructive and mutually beneficial way. The QA managers of GCP-Service have more than 13 years Quality Assurance of clinical research experience. They can support you with risk management in your company, and we can help to develop efficient systems capable of reducing risk and Project Management enhancing in-house quality. Report Risk Evaluate Risk Generate Alerts Figure 4 Process of risk reporting, risk evaluation and risk alerting by QCTMS Try Us One 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 Figure 3 Risk Management via QCTMS according to ICH Q9 We look forward to being of service to you!
- 7. 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 59 E-Mail info@gcp-service.com / www.gcp-service.com