Professional handling of the clinical trial site is critical for the success of the study. ClinCore provides expertise, administrative staff and onsite management for successful study completion, high-level performance and the assurance of quality and safety.
ClinCore’s services, based on years of accumulated experience, are essential for conducting a successful trial. ClinCore enables the healthcare team to focus on their medical activities.
Our services encompass the entire lifecycle of the clinical trial:
- Coordinating the trial activities onsite
- Planning and establishing clinical trial units to meet study goals and regulatory requirements with maximum effectiveness:
- Implementation of quality systems according to ICH-GCP
- Development and implementation of internal SOPs
- Preparation of worksheets, questionnaires, study-specific forms and tracking tools
- Submission of pack preparation, obtaining approvals from ethics committees and regulatory authorities
- Training of study staff and the parties involved in the trial: laboratory staff, pharmacists, dietitians and more.
|
