Our teams have certainly many years of experience in a huge variation of different medical areas such as:
We conducted more than 10 clinical studies in these areas:
Challenging 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 new EU Medical Device regulation 2017/745, the requirements for performing clinical studies for data supporting the performance and safety of medical devices have been implemented. If you need clinical data for your product, you need an experienced partner. GCP-Service supports you conducting the clinical study regardless whether a CE marking is intended or already placed, whether a class I or a class III device, whether in Europe or the rest of the world.
The development of combination products, utilising the physical benefits of medical devices together with the pharmaceutical effects of drugs, will be one of the great challenges of the current century. However, medical devices and pharmaceutical products differ extremely in terms of history, philosophy and regulations. To successfully combine these, you have to draw on expertise for both. GCP-Service offers this: if you want to develop your product, please contact us. We are here to support you!
We have conducted studies with medical devices or combination products in following indications:
• Bladder cancer
• Breast implants
• Cervical cancer
• Cervical degenerative disc disease
• Chronic obstructive pulmonary disease (COPD)
• Colon cancer
• Cruciate ligament rupture
• Dermal fillers
• Diabetes mellitus
• Geographic atrophy
• In vitro diagnostics (IVDs)
• Mitral valve regurgitation
• Primary resurfacing arthroplasty
• Retinitis pigmentosa
• Shoulder hemi arthroplasty
• Thoracic adolescent idiopathic scoliosis
• Ulcerative colitis
Non-interventional Studies (NIS) or post-marketing surveillance studies are an indispensable instrument in pharmaceutical research and the medical device industry. Due to the fact that clinical Phase I-IV trials with pharmaceuticals or medical devices provide us with a limited number of data within a selected study population, we need high-quality post-marketing surveillance studies to receive more information about their use under real-life conditions which reflects the medical routine practice. Hence reliable NIS data have a direct impact on the evolution of pharmaceuticals and medical devices. Although the budgets for these studies are usually quite limited, this should not be a reason for poor quality. We are experts in conducting non-interventional studies. GCP-Service conducts NIS cost-efficiently without losing sight of quality requirements.
We offer for your NIS:
• Low cost eCRF solutions
• Electronic Patient Reported Outcomes solutions (ePRO)
• 5-20% or more Source Data Verification by experienced CRAs
• Remote monitoring
• Preparation of Patient Informed Consent Forms and Investigational Plans
• Submission of study documents to Ethics Committee and follow-up on approvals
• Valid sample size calculation – Statistical analysis and delivery of the Study Report
GCP-Service conducts your NIS with your product in Europe. We work according to high quality standards based on the following currently accepted principles:
• Recommendations of the Association of Research-based Pharmaceutical Companies (VFA) for the conduct of NIS (Jan, 2007)
• Recommendations of the Federal Institute for Drugs and Medical Devices (BfArM) and the Paul-Ehrlich-Institute (PEI) (draft from May 2007)
• FSA codex (August 08) – German Drug Law (AMG, paragraph 67.6)
• Declaration of Helsinki where applicable – Good Clinical Practice where applicable
For medical device manufacturers we run small studies with CE marked medical devices to confirm the CE mark. If you have a CE marked medical device but you have problems with selling your products we can support you to receive a tool number (German: Hilfsmittelnummer) to get reimbursement.
Cancer 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 recent years, few effective treatments have been developed and licensed to treat certain cancers. Some companies do have very promising drugs in the pipeline. However, the mortality rate of cancer patients is far too high and much more clinical research is needed to decrease this rate significantly. Oncological studies have to adhere to special rules, which 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 a wide range of oncological studies, including the handling of orphan cancer diseases. We have performed phase I, II, III, IV and non-intervention clinical studies for the following indications:
• Adrenocortical carcinoma
• Bladder cancer
• Breast cancer
• Cervix cancer
• Colon cancer
• Gastric cancer
• Head cancer
• Lung cancer
• Neck cancer
• Pancreatic cancer
• Renal cell carcinoma
• Non-solid cancers:
• Malignant lymphoma
Fitness to Drive and Medicines
Clinical Trials on Driving Fitness and Ability under medicinal drugs become more and more important to maintain mobility and improve traffic safety.
• The acquired information can help physicians to choose a drug causing the least impairment of driving fitness from therapeutically equivalent substances.
• It can support patients to optimize their mobility by supplementing package inserts (e.g. about dose dependence or duration of impairment, interaction with alcohol etc.).
• For producers appropriate studies offer the opportunity to prove superiority over competing substances and to avoid or attenuate warning notices.
In cooperation with our qualified partner WIVW (Wuerzburg Institute for Traffic Sciences) we provide support in planning, implementing, evaluating and publishing ICH/GCP clinical studies on driving fitness and ability. For this purpose, various driving simulators at different configuration stages (from essential to high-end) are available.
The benefits of clinical trials with WIVW driving simulation systems include:
• risk-free, highly standardized investigation of driving performance
• representative test scenarios with empirically documented sensitivity to a variety of neurological disorders and psychoactive substances
• a selection of well-founded endpoints for evaluating driving ability according to a performance profile based on traffic psychological expertise
• full compliance with the Guidelines on Experimental Studies Undertaken to Determine a Medicinal Drug’s Effect on Driving or Skills Related to Driving of the International Council on Alcohol Drugs and Traffic Safety.
The applied methodological approach has been validated in an extensive alcohol calibration study published in the Journal of Clinical Psychopharmacology (Driving Performance Under Alcohol in Simulated Representative Driving Tasks) and awarded with the German Traffic Safety Award of the Federal Highway Research Institute 2012 (2. Place; News Release of BASt) as well as with the Best Poster Award of the Annual Meeting of The International Society for CNS Clinical Trials and Methodology in Washington in February 2013 (9th Annual Scientific Meeting).