- We enable smooth and harmonized study medical and safety monitoring and management, through knowledgeable, responsive and friendly approach to Site Personnel.
- We always engage in efficient bidirectional communication between Medical/Safety Representative and Clinical Operation team members thus facilitating uniform decision-making process in a timely manner.
Our medical and safety monitoring coverage is designed to assist You in:
Start-Up Activities through:
- Protocol and electronic case report forms (eCRFs) development and review.
- Sites, Investigator/Key Opinion Leaders (KOL) identification.
- Creation of Medical and Safety Monitoring Plan.
- Site initiation.
- Identification of effective enrolment strategies for specific sites.
- Provision of therapeutic and project-specific training to operational team members and sites.
Our Ongoing Trial Activities include:
- 24/7 full time service Medical and Safety Monitoring.
- Motivational calls to investigators and study coordinators throughout trial.
- Active engagement with clinical research associates (CRAs) and project managers in discussions related to day-to-day patient care.
- Clarification of medically relevant study conduct issues to clinical operations team members.
- Assisting the sites regarding accurate screening, inclusion and exclusion of study participants.
- Assisting the project team on identifying needs for protocol amendments.
- Collaborating with sponsor medical and pharmacovigilance teams in case of working for a CRO.
- Reviewing of lab reports, AEs and SAEs, protocol deviations and violations and their respective classification into major or minor.
- Continuous Medical Management of Clinical Trial Subject Emergencies.
Our Close-out Activities include:
- Reviewing of Final Tables, Listings & Figures (TLF).
- AE and SAE review and MedDRA coding.
- Writing and/or Reviewing of Clinical Study Report (CSR).
- Strategic evaluation of study outcomes with Sponsor in case our services are provided via a CRO.