Life -Long Partners In Drug Development
Lifepoint is well known as the Best Clinical Research Institute in Pune & India. It has the best-in-the-class infrastructure for conducting clinical trials and a large and diverse therapy-naive patient pool to tap as well. We have well established research setup in 4500 square feet, which includes reception area, working station, Separate & access controlled pharmacy to meet all temperature needs (2 to 8 degree C, 15 to 25 degree C, -24 to -80 degree C), Monitoring rooms / Auditor Room/ Conference room. Research oriented qualified & experienced research Staff of 28 Study Coordinators, Site manager, quality manager, phlebotomists, Research Nurses & Other supporting staff.
Site has been inspected by:
- Local regulatory agency (DCGI) in May 2018 with no observations
- US FDA in June 2018 & July 2021 with no form 483
- WHO & AIFA in Dec 2019 with no major finding (we are now qualified site for WHO studies)
- In the last 7 years we have conducted 38 patient based bioequivalence studies, 90+ phase studies & 6 investigator initiated studies at this center in various indications.
- The Institutional Ethics Committee is Registered in CDSCO (ECR/751/INST/MH/2015/RR-21), also EC has been inspected for NABH.
- Site is registered with USFDA with FEI number- (3012051676) & (DUNS No. 650960482)
- Clinical laboratory is NABH & CAP certified & in the near vicinity with the turnaround time for getting reports 4 hours for Hematology & Biochemistry and within 24 hours for other tests.
- Management team having total domain experience of 13 Years and have successfully completed 400 plus trials with a variety of indications along with vaccine trials. We have closely worked with all the major domestic & Global Pharmaceutical companies.
Our Clinical Partners
Our Clinical Partners
We are ISO 9001:2015 Certified
Full Service SITE with phase 1, 2, 3, and 4 clinical trial services
Study Feasibility & Investigator Selection Site Qualification & Site Initiation visits Monitoring & Audit visits Correspondence with Ethics committee
Central/Local Lab logistics ICH GCP Trainings Site Closeouts
AE, SAE Reporting Completion of Paper/ e-CRFs and resolving Data Queries Document Maintenance, Updating & Retention
Assistance in ICF process Screening & Randomization of the subjects Subjects follow-up visits
Serving 15 Major Therapeutic Areas in Clinical Research
Pediatrics
Comsmetics
Oncology
Gyn. & Obs.
Ophthalmology
Neurology
Expert-Backed PG Diploma Program
The future of clinical research is bright and limitless. A PG Diploma Clinical Research Courses in Pune prepares students for careers in the healthcare field. In other words, this course provides the necessary skills and qualifications needed for the professional practice of Clinical Research Services in Pune. Students pursuing this course can make their career in the following:
- Healthcare and pharmaceuticals
- Nutrition and public health
- Bioinformatics, and drug designing
- Biomedical engineering
- Analytics,forensic sciences
- Food and beverages
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