Our goal as a Clinical Research Organization is to serve as a pivotal partner of sponsor to enhance the drug and medical device development process. With a team of expert with rich experience of handing highly challenging clinical trials, we at ClinNext offer following services for Phase 1, 2, 3 and Phase 4 clinical trial of medical devices, drugs and modified release formulations, new drug delivery systems, biologics, biosimilars and vaccines.
INVESTIGATOR INITIATED STUDIES:
Investigator-initiated studies (IIS) are research projects that are initiated and conducted by a single investigator, institution, university, cooperative group, or association. We offer tailored solutions for IIS right from the development of study documents to closeout and report writing while maintaining the independence of the Investigator and complying with guidelines.
Start-up Activities
- Study Document Development
- eCRF and Database Development
- Translation of Study Documents
- Ethics Committee and Regulatory Submissions
- Project Planning
Study Conduct Phase Activities
- Supporting Patient Enrolment
- Monitoring
- Safety Reporting
- Data Management
- eTMF Maintenance
Study Close-out Activities
- Statistical Analysis
- Study Report Preparation
- Manuscript Writing
- Presentation Preparation for Conferences
- Archival
PMS Studies
Post Market Surveillance is a series of activities carried out by manufacturers to monitor the medical devices or drugs already on the market and to determine whether any further action is required. PMS is also known as real-world evidence or Post Market Clinical Follow-up (PMCF).
- Development of PMS/PMCF plan
- Implement PMS/PMCF Plan
- Collection and Analysis of Data
- Detection of Serious Event
- Generate PMS/PMCF Reports
- Preparation of Periodic Safety Update Report (PSUR)