Clinical Strategy & Development Services

1. Tailored Solutions for Pharmaceutical and Biotech Companies
2. Expert Guidance for Optimizing Clinical Trials
3. Streamlining Product Development for Success
4.Ensuring Regulatory Compliance throughout the Process

The clinical strategy and development team is an international group of experienced professionals trained in clinical medicine and research, (molecular) biology, and pharmaceutical sciences. Their extensive scientific experience in industry and academia will bring your clinical development projects to success.

The team offers hands-on support with in-depth consultancy and medical writing for pharmaceutical products and medical devices:

Pharmaceutical Products

Clinical development

• Clinical development strategy
• Clinical development planning (scientific and economic)
• Clinical study synopsis and protocol
• Investigator´s brochures
• Project feasibility assessment and gap analysis
• Scientific justification for reclassification of products (Rx- and OTC-switch)
• Biowaiver justification

Clinical trial

• Clinical trial planning, management, and oversight
• Clinical trial application
• Compilation, maintenance, and archiving of clinical trial masterfiles
• Legal representative in the EU
• Evaluation and interpretation of clinical trial results

Scientific advice procedures (EMA, national competent authorities)

• Strategy
• Briefing documentation
• Organisation and support of procedures

Marketing authorisation procedures

• Dossier preparation (CTD Ms 2.5, 2.7, 5)
• Product information texts
• Risk management plan (M 1.8.2)
• Handling of assessment reports

Medical & scientific writing

• Systematic literature searches
• Drafting of scientific articles for publication

Paediatric investigational plans (PIP)

Orphan drug designations

• Protocol assistance for orphan drugs

Due diligence for in-licensing candidates

Identification of qualified service partners, key opinion leaders and scientific experts

Medical Devices

Clinical investigation

• Gap analysis of clinical data set
• Clinical investigation synopsis and clinical investigation plan (CIP)
• Investigator’s brochure
• Application / notification
• Communication with ethics committees and authorities
• Clinical investigation oversight, evaluation and reporting

Clinical evaluation (MDR EU 2017/745) / Performance evaluation (IVDR (EU 2017/746)

• Preparation of a clinical / performance evaluation plan (CEP / PEP)
• Clinical / performance evaluation report (CER / PER)
• Summary of safety and clinical performance (SSCP), Summary of safety and clinical performance (SSP)
• Regulatory assessments and gap analysis for project assessments

Post-market surveillance

• Post-market surveillance plan
• Post-market surveillance report / PSUR
• Post-market clinical follow-up (PMCF) plan and report / Post-market performance follow-up (PMPF) plan and report
• Systematic literature search, search in vigilance databases, analysis of data

Trainings / workshops on MDR requirements for:

• Clinical evaluation, post-market surveillance, post-market-clinical follow-up

Due diligence for in-licensing candidates

Have a question concerning Clinical Development? contact Dr. Andrea Niese.