Clinical Operations

Clinical operations are a critical component in all studies. From start-up to close-out, our highly skilled clinical operations teams ensure proper planning, conduct, patient safety, and data quality, while fostering good communication between study sites and sponsors.

Our clinical trial managers provide leadership and operational expertise through collaborative planning, implementation, and execution. Clinical research associates work closely with your team on protocol and indication training, building strong site relationships, and ensuring site compliance. Finally, our wide network of clinical trial experts throughout in India, and alliances with long-established partners in Europe, USA and South Africa, ensures global consistency, support, and a high standard of quality, meeting ICH-GCP guidelines, wherever in the world we manage your clinical trials.

Whether helping with an overload of work or designing a full-service clinical program, our experienced, knowledgeable team is ready to partner with you to develop a program customized to your needs.

Clinical operations services include:

  • Worldwide feasibility studies
  • Study start-up including site identification, qualification, and selection
  • Study document development
  • Essential document collection and maintenance
  • Translations
  • Trial Master File set-up and maintenance
  • Site monitoring and management
  • Patient recruitment and retention strategies
  • Clinical trial management system
  • Training of clinical associates
  • CRA management and quality control
  • Audit preparation
  • IRB/EC submissions
  • Third-party vendor management

We’re your best partner. Our goal is to provide you with the services that best meet your needs, and responsible trial monitoring handled by experts. Tell us your challenges – we’ll help you determine your best course of action.

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