Clinimerck Global Research Solutions
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
What we CAN DO
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:
- Clinical scientists well versed in medical writing
- ICH-GCP certified professionals experienced in clinical trial
- Skilled-technicians working in clinics, laboratories and pharmacy
- Panel of doctors for expert opinion and peer reviews.
We can provide a well organized, methodically planned and carefully conducted trial for your reseach.
Services List
Clinical Trial Management
- Protocol Development
- Project Management
- Regulatory Services
- Site Evaluation and Selection
- Central Lab Services
- Clinical Trial Supply Management
- Site Management
- Medical Monitoring
- Quality Assurance
- Medical Writing
- Statistical Analysis
Clinical Data Management
- CRF design, printing & distribution
- Database design & setup
- Edit checks programming
- Double data entry
- Data validation & discrepancy management
- Medical coding
- SAE reconciliation
- Integration of third-party data
- Database lock & archival
Regulatory Affairs
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.
Site Management
Pre – Trial Activities
Pre – Trial Activities
Pre – Trial Activities
· 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
Trial Conduct
Pre – Trial Activities
Pre – Trial Activities
· 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.
During the Trial
Post-trial activities
Post-trial activities
· 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.
Post-trial activities
Post-trial activities
Post-trial activities
· Coordinate close out visit
· Resolve data queries on time in coordination with Investigators
· Archival of Data
· IP Destruction