Once your needs have been clearly identified, the Scientific & Regulatory Affairs Department will prepare a study design that best acommodates development needs and effective study conduct. This team of experienced scientists integrates innovation, expertise and the latest scientific and regulatory development requirements in order to provide accurate and up-to-date results.
This team is composed of seasoned scientific staff with different backgrounds. They maintain a strong, continuous relationship with each client as well as with regulatory agencies around the globe. With their broad range of experience, the team can serve as a reliable reference for both scientific and regulatory issues.
Our scientists can provide data transfers and electronic submissions for Clinical Evaluation. All documentation is provided in Report Templates (CTD, ICH) and electronic Abbreviated New Drug Applications.
Further department services include:
- Statistical plan development
- Pharmacokinetic analysis
- Data Management
- SAS code programming
- Integrated study reporting
- Custom format reporting
- Pharmacokinetic/Statistical reporting