Trials of medicinal products today often involve highly advanced therapies that require specialist knowledge of regulatory requirements. We apply our global regulatory expertise to ensure efficient and effective regulatory applications. With more than 28 years of experience in delivering clinical development programs globally in a broad range of therapy areas, ClinChoice delivers efficient start-ups and ensures that patient enrollment commences on schedule.
Pharma & Biotech
Regulatory Expertise
Our global team consists of local staff with a deep understanding of regional regulatory requirements. We’re constantly monitoring the global regulatory landscape, tracking changes in legislation, guidelines, and regulations that apply to drugs of all types and mechanisms of action. We utilize our expertise to develop an effective regulatory strategy, define the required documentation, and coordinate translations to ensure a complete application package for authorities and ethics committees.
Comprehensive Start-Up Services
Based on rich clinical research experience, extensive site knowledge, and pharmaceutical and biotech backgrounds, our study start-up experts excel in personalized project management and site start-up organization. From project onset, we support clients with professional interpretation of regulations and site processes, helping to lead studies and save time in recruitment.
- Comprehensive site setup
- Competent Authority / Health Authority submissions and approvals
- Ethics Committee (EC) submissions and approvals
- OHGRA application processing (China only)
- Investigator site contract negotiations and signoffs
- Essential documents collection
Scope of Start-Up Services
We specialize in developing and implementing site initiation strategies for pharmaceutical and biotech clinical trials of all phases aligned with protocols, contractual scopes, SOPs, and GCP requirements. Our commitment extends to risk management and strategic support for swift, high-quality start-up solutions.