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Excellence in Execution

Ethicare provides End-to-End services from Phase I Bioequivalence study in special patient population to Phase II proof of concept study, Phase III regulatory submission multicentric studies to Phase IV / PMS / RWE or observational studies by maintaining the highest standards of ethics, quality and confidentiality in line with applicable regulatory guidelines. We have provided our clinical research services to Pharmaceutical, Biotechnology, Medical Device, Cosmetic and Nutraceutical companies.Whether through Central Monitoring, Remote Monitoring, or on-site monitoring, we ensure seamless execution and optimal results for your clinical development programs.

Contributions To Science

0 +

Clinical trials performed

> 0

Patients recruited

> 0

Clinical sites

0 +

USFDA audited sites in database

0 +

Physicians GCP trained

0 CRO

CRO

Therapeutic Expertise

Cardiovascular

5%

Dental

3%

Dermatology

21%

Endocrinology

13%

Gastroenterology

5%

Gynecology

11%

Hepatology

5%

Nephrology

2%

Onco & Hemato

12%

Pain Management

8%

Psychiatric

10%

Respiratory

5%

Ethicare’s Clinical Trial Management services include:

  • Setting up study-specific procedures and documents, such as:
  • Site Feasibilityand identification plan
  • Investigator database across various Therapeutic Areas
  • Site Qualification
  • Contract Negotiation and Implementation
  • Grant Management and Payment Administration
  • Agreements
  • Patient Recruitment Plan
  • Patient Retention Strategy
  • Monitoring Plan
  • Trial Master File (TMF)
  • Investigator Site Master File
  • Laboratory Manual and Diagnostic
  • Open Label Extension Study
  • Training for study specific-procedures
  • Project Management - Coordination of all study-related activities in all participating sites and between all involved stakeholders
  • Global Program Coordination and Oversight
  • Project Transition and Rescue Management

Management of Vendors and External Partners

Global clinical trials usually involve many different parties and vendors. The Ethicare Clinical Trial Management team provides a pivotal contact to all involved parties, such as:

  • Central Laboratories / Local Laboratories
  • Imaging Centre
  • Investigational Medicinal Product Logistics
  • Data Monitoring Committee
  • Ethics Committee (IEC/IRB)
  • Interactive Voice/Web Record Systems (IRS)
  • Archival Vendor
  • Translation Vendor

Meeting

Ethicare’s Clinical Trial Management team can organize meetings for your trial, such as:

  • Investigator meetings
  • Monitor meetings
  • Data Monitoring Committee meetings

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