Clinimerck can help you choose the clinical trial model, whether it's traditional, customized, decentralized, or hybrid, that best addresses the study's clinical development challenges
The safety and efficacy of medications, devices, diagnostic products and treatment regimens intended for human use is studied under Clinical Research. It is the bloodline of all medical advances.
We build smart, adaptable ways that take advantage of clinical-informatics, cutting-edge technology, and worldwide reach to improve research outcomes.
Our team consists of:
We can provide a well organized, methodically planned and carefully conducted trial for your reseach.
We continuously monitor today’s complex and ever-changing global regulatory landscape to efficiently deliver quality regulatory services and submissions.
Our global presence enables us to bring a deep understanding of local regulatory requirements to every project, keeping your research on time and on budget.
· Identify potential GCP trained sites / Principal Investigator.
· Provide GCP training to PI & study team at a regular basis.
· Provide GCP trained Clinical Research coordinators for every site.
· Identify and coordinate preparation & submission of essential documents to CRO/ Sponsor.
· Ethics committee submission & approval with turn-around time.
· Site set up & essential document preparation.
· Create source document template if applicable.
· Prepare site for Site Initiation Visit. · Pre-screening/ pre-identify cases for competitive trials
· Planning Recruitment Strategies
· Assist the Investigator in the ICF process, screening & enrollment.
· Implement recruitment strategies
· Maintain source documents in guidance with Investigator team.
· Completion of CRF/ eCRF with in specified timelines
· Maintain and update Trial Master File.
· Dispense Investigational product & maintain drug storage & accountability as per the requirements.
· Coordinate Central Lab logistics & sample flow.
· Coordinate subject follow-up visits & preventing lost to follow up
· Coordinate subject reimbursements.
· Coordinate Monitoring & Audit visits.
· Coordinate SAE reporting on time maintain documentation.
· Coordinate and maintain the ethics committee documentation during the study.
· Coordinate close out visit
· Resolve data queries on time in coordination with Investigators
· Archival of Data
· IP Destruction