How to Set Up a New Clinical Trial Site: A Step-by-Step Guide
Setting up a new clinical trial site can be overwhelming. From infrastructure, staff recruitment, and documentation to ethics approvals and regulatory compliance—each step needs careful planning and execution.
That’s where Doclin Clinical Research Services (DoclinCR) comes in. We help you at every stage, making your site fully trial-ready, compliant, and sponsor-friendly.
Here’s a step-by-step guide to setting up a clinical trial site, along with how DoclinCR supports you throughout the process.
✅ Step 1: Site Feasibility – Is Your Site Ready?
Before any sponsor considers your site, you must assess whether it meets basic feasibility requirements—like access to eligible patients, infrastructure, and investigator availability.
🔹 How DoclinCR Helps:
- Conducts detailed site assessments
- Assists with sponsor feasibility questionnaires
- Highlights your site’s strengths to improve trial selection chances
✅ Step 2: Legal and Regulatory Setup
You need to be aligned with all legal and regulatory requirements, including:
- Clinical Trial Agreement (CTA)
- Confidentiality Disclosure Agreement (CDA)
- CDSCO registration (for India)
🔹 How DoclinCR Helps:
- Drafts and reviews CDAs/CTAs
- Registers your site with regulatory authorities
- Ensures all regulatory documentation is complete and compliant
✅ Step 3: Infrastructure and SOPs
Every clinical trial site needs standard infrastructure and well-documented SOPs. This includes rooms for consenting, drug storage, sample processing, etc.
🔹 How DoclinCR Helps:
- Shares infrastructure checklists tailored to trial needs
- Supports equipment procurement and calibration
- Helps develop SOPs for documentation, IP handling, safety, etc.
✅ Step 4: Staff Recruitment and Training
You need qualified staff—Principal Investigator, CRC, pharmacist, lab technician—and each must be trained in GCP, protocol, and trial operations.
🔹 How DoclinCR Helps:
- Provides trained CRCs and research professionals
- Conducts GCP, protocol-specific, and site SOP training
- Maintains training logs and certificates
✅ Step 5: Ethics Committee (EC) Submission and Approval
EC approval is mandatory before any trial activities begin. Submitting a complete application and responding to queries quickly is crucial.
🔹 How DoclinCR Helps:
- Prepares EC submission packages, including ICFs, CVs, undertakings, etc.
- Writes SOPs and ensures adherence to EC submission guidelines
- Resolves EC queries and acts as a bridge between PI, EC, and Sponsor
✅ Step 6: Site Initiation Visit (SIV)
The SIV is conducted by the sponsor/CRO to ensure the site is ready to begin the trial. Documentation and staff readiness are critical.
🔹 How DoclinCR Helps:
- Prepares logs (delegation, screening, training) and source templates
- Supports mock SIVs to identify and fix gaps
- Helps with documentation setup, IP management, and lab coordination
✅ Step 7: Subject Recruitment and Trial Execution
Once approvals are in place, the site can begin enrolling participants and conducting the trial per the protocol and ICH-GCP.
🔹 How DoclinCR Helps:
- Supports patient recruitment through referrals and outreach
- Ensures proper consenting and documentation practices
- Tracks recruitment, protocol compliance, and data quality
🛠 Bonus: Avoid Common Pitfalls
Some frequent mistakes include incomplete EC submissions, lack of staff training, and poor source documentation.
🔹 How DoclinCR Prevents These:
- Audits site processes regularly
- Offers continuous training and SOP refreshers
- Provides templates, trackers, and real-time support
Setting up a clinical trial site is complex—but with the right partner, it becomes a streamlined, efficient process.
DoclinCR doesn’t just consult—we work alongside you to build a research-ready, sponsor-compliant, audit-proof site.
🚀 Thinking of starting a clinical trial site? Let us make it easy for you!
📞 Contact Doclin Clinical Research Services today.