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Regulatory Start-Up & Contracting

From protocol to first-patient-in, without the delays.

Why It Matters

A study cannot start until its documents, approvals and agreements are in place. We help sponsors, CROs and sites move faster from protocol to first-patient-in, with complete, compliant start-up packages and clear milestone tracking.

Who It Is for

Sponsors, CROs, SMOs, investigators and hospital research departments.

See the serviceBrochure

What We Cover

  • Drafting, reviewing and negotiating CTAs, MSAs and CDAs
  • Protocol amendments, ethics committee submissions and CTRI documentation
  • Start-up milestone tracking, investigator budgets and turnaround optimisation
  • eTMF set-up and operational metric tracking

Benefits

Faster Activation

Parallel document, contract and ethics workflows.

Fewer Queries

Submissions prepared right the first time.

Clear Visibility

Milestone trackers you can share with sponsors.

Inspection-Ready

Start-up documents filed correctly in the eTMF.

Related Courses

Regulatory, quality & writing

Regulatory Affairs in Clinical Research

Approvals and submissions for trials in India and abroad: CDSCO, SUGAM, CTRI, ethics and global agencies.

  • 5 weekends
  • Live online with recordings · Next batch: on request
  • Pharmacy and life sciences graduates
What you will learn
  • NDCT Rules 2019 and CDSCO pathways
  • SUGAM portal and CTRI registration
  • Ethics committee submissions
  • US FDA, EMA and ICH overview
  • Regulatory documents and dossiers
Short course
Clinical research & operations

GCP Essentials: ICH E6(R3), NDCT Rules & ICMR Ethics

A focused refresher on current Good Clinical Practice for students, faculty and site staff.

  • 1 weekend
  • Live online with recordings · Next batch: on request
  • Students, faculty, investigators and site staff
What you will learn
  • The ICH-GCP principles in practice
  • Roles of sponsor, investigator and ethics committee
  • NDCT Rules 2019 essentials
  • ICMR National Ethical Guidelines
  • Case-based assessment

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