ServicesSummarized

A wide range of scientific and regulatory consultancy services are provided. These draw on the expertise available within Charité Research Organisation and on the leading therapeutic area expertise available within the Charité. Regulatory consultancy is provided by a team that includes members with a “Competent Authority” background. Scientific consultancy utilizes internalized expertise and organizational capabilities coupled with that of therapeutic area experts to address very specific questions and requirements. Examples of the work undertaken include:

• Assessment of current regulatory thinking and expectations
• Development planning with a regulatory perspective
• Study conceptualization with input from therapeutic area experts on endpoint, technology and biomarker selection
• Expert evaluation of clinical available investigational product data and clinical trial results
• “Overworking” and review of regulatory authority submission packages
• Evaluation of the benefits and requirements of/for additional studies
• Pediatric Investigation Plans (PIPs)
• Regulatory applications (e.g. orphan drug applications, CTAs)
• Assistance with the formation of expert advisory panels

The aim of the Project Management team is to provide sponsors with an unrivaled experience in respect of their interaction with Charité Research Organisation. This is achieved by a commitment to provide fast, effective response and to facilitating a seamless management of internal study activities and those undertaken by partners.

A multi discipline approach is taken to study design. Effective study design has to take into account not only the desired outcome but also regulatory realities and requirements. Charité Research Organisation is able to provide input from therapeutic area experts to ensure selection of the most appropriate endpoints, technologies to investigate them and guidance on viable inclusion and exclusion criteria. A regulatory perspective is applied to ensure that the design – and in particular the design of complex, multi-part, adaptive design studies – is laid out in a fashion that takes account of and facilitates regulatory process and requirements.

Regulatory and Ethical Committee submission are handled by an effective collaboration between Project Management and the Scientific and Regulatory Services group. Charité Research Organisation has developed a proven approach to facilitating successful multi-part, multi-population study applications in Germany. As a consequence, an increasingly large number of sponsors are either delegating full CTA responsibility to CRO or are working closely with CRO on CTAs for complex FTIH and Phase I studies.

Charité Research Organisation operates a Phase I unit located in the main Charité hospital tower in central Berlin. This research unit provides 40 beds, direct access to emergency and intensive care facilities, a wide range of internal diagnostic equipment and support seamless collaboration with the surrounding clinics.

Charité Research Organisation focuses on the conduct of FTIH to POC studies. This includes typical healthy volunteer studies along studies that go beyond what has conventionally been considered viable. Most notable in this respect is the track record of CRO in completing complex multi-part FTIH studies in patients as single center studies. CRO is also supporting multi-center studies in early clinical development and supports novel approaches to ensure that maximum benefit can be gained from available technologies and biomarker expertise even in a multi-center context.

Charité Research Organisation provides and utilizes internal monitoring capabilities along with external partnerships.

Charité Research Organisation has established partnerships with a selection of well established, well renowned Data Management providers. This ensures that optimal solutions can be presented where data management is to be outsourced. Technologies available include eCRF and online data visualization capabilities. CROs partner laboratory is also able to provide electronic data transfer is sponsor required formats and also provides real-time online access to laboratory data.

Charité Research Organisation works with select partners to provide a full range of statistical evaluation services. This includes both internal and external PK expertise and analysis.

Medical writing services are provided by experienced medical writers within the Scientific and Regulatory Services group to cover a wide range of requirements. Services include:

• Protocol development
• Investigator brochures
• IMPDs
• Clinical trial reports
• Briefing documents