Services

Edenwell offers complete site management services to Pharmaceutical and Biotechnology companies, Contract Research Organizations, etc. using its extensive network of well-known investigators across India. Its dedicated team ensures that patient recruitment and retention is achieved with the highest quality and ethical standards by supporting the investigators in the management of patients and the conduct of the clinical trials at sites.

The site management model is based on our sites composed of dedicated facilities with both permanent and contract Clinical Research Coordinators (CRCs) and Study Nurses at the trial centres. The CRCs and study nurses support the investigators in the management of patients and in administrative activities.

The research centres are actually centres of excellence with dedicated temperature controlled drug storage facility, documents storage area, patient examination rooms, certified laboratory and space for monitors.

Edenwell has its own well trained and constantly expanding CRC pool. CRCs are deployed at the investigative sites based upon their demographics, prior experience with the same site, same therapeutic area, same sponsor, etc. The CRCs go through a training curriculum that equips them to efficiently support the study at the investigative site.

1. Our Clinical Trials Network across India makes us the fastest responders to a feasibility request for a clinical research project
2. Our years of experience in the field as well as our large network of affiliates give us access to thousands of potential subjects.
3. We have a strong team of investigators, research coordinators, and study nurses who have years of experience in conducting and managing clinical trials geographically distributed across India
4. Excellence in Managing of Phase I, II, III, IV clinical trials & BA/BE studies
5. Budget optimization and finalization of the contracts in quick turnaround time through our office
6. Complete regulatory documents with rapid turnaround time
7. Assist sites with recruitment strategies to enroll subjects
8. Provide ongoing on-site development training for our investigators and staff to ensure our sites are consistently producing the required results
9. Readiness for quality assurance audits to ensure consistent quality data is collected
10. Provide another level of contact outside the site
11. Quality source documentations & other site documents.
12. Sites that are top enrollers nationwide on multiple studies by virtue of their inherent merits