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ICH E6(R3) Ready  ·  Phase I–IV  ·  India · UK · USA

Global CRO Where Science Meets Results

10 Years
Delivering Exceptional
Clinical Science
Excellence  ·  Integrity  ·  Accountability
Founded 2015  ·  Bengaluru · London · Boston

Biosite Research is a full-service global CRO offering end-to-end clinical trial solutions for pharmaceutical, biotech, medical device, and nutraceutical companies worldwide.

Who We Partner With

Built for Innovators Who Need Results

Pharmaceutical and biotech companies worldwide — delivered with the same scientific rigour and the same accountable team.

Dr. Aditi Datta — Founder, Biosite Research
Founding Vision · Scientific Leadership

"When I started Biosite, I envisioned a CRO that global pharma and biotech could trust completely — not just to execute trials, but to think alongside them. Every study we run is built on precision, powered by data-driven decisions, and driven by one goal: getting breakthrough therapies to patients who need them most."

Dr. Aditi Datta
Founder & Director · Biosite Research
MBA (IIM-K) M.Res in Drug Development (UCL)
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Pharmaceutical Companies
End-to-end clinical trial solutions for Phase I–IV programs, NDA/ANDA filings, and multi-regional submissions to USFDA, EMA, and CDSCO — global-standard execution at India-based efficiency.
Pharma Solutions
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Biotech & Emerging Innovators
First-in-human studies, adaptive trial designs, and orphan drug programs. We act as your dedicated scientific partner — accountable for outcomes, not just managing timelines.
Biotech Solutions
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Clinical Trials
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Indications
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Investigators Database
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Sites Database
Our Services

Clinical Trial Services, End to End

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Feasibility & Study Setup
Study Setup
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Clinical Trial Management
Phase I–IV
📁
Regulatory Services
Regulatory
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Biometrics & Data Management
Biometrics
🛡️
Pharmacovigilance & Safety
Safety
✍️
Medical & Scientific Writing
Writing
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Real World Evidence
RWE
⚙️
Quality & Project Management
Quality
Scientific Depth

Our Therapeutic Areas

Deep expertise across 33+ trial indications — from oncology to rare disease.

View All Therapeutic Areas →
Why Biosite

Real Reasons Sponsors Choose Biosite

01
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Same team, start to finish
The scientists who review your protocol run your study. Named principal accountability — you always speak to the decision-maker, not a helpdesk.
02
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Science is built in, not added later
Biometrics, regulatory strategy, and medical monitoring sit at the same table as clinical operations from day one. Your SAP is regulatory-grade before first patient enrolled.
03
Faster without cutting corners
820+ site database, pre-qualified investigator networks, and streamlined IRB processes. Speed comes from preparation — with a USFDA Zero-483 inspection track record to prove it.
04
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World-class science. Competitive Budget.
Biosite's science is benchmarked against the most demanding global regulatory standards. Our operational model lets sponsors access that standard of rigour without the overhead of large, multi-layered CRO structures.
Insights & White Papers

Science from the Field

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White Paper
Zero-483 USFDA Inspection: How Biosite Achieved It Twice
Quality Team · Regulatory · 2024
Biosite achieved Zero-483 on USFDA inspections for ARDS (2024) and Open Angle Glaucoma (2016). The quality framework and inspection readiness protocols that made it possible.
USFDAQualityGCP
Disease Report
GLP-1 Receptor Agonists: Real-World Evidence Landscape 2025
Science Team · RWE · 2025
Post-approval analysis of semaglutide and tirzepatide outcomes — implications for trial design, endpoint selection, and HEOR submissions.
GLP-1RWEMetabolic
Article
ICH E6(R3): What Every CRO Needs to Do Differently Right Now
Regulatory Affairs · 2025
The updated GCP guideline changes risk-based monitoring, TMF quality, and protocol oversight. Biosite's readiness framework.
ICH E6(R3)GCPRegulatory
Global Operations

India. UK. USA. One Team.

Three strategic hubs — complete clinical, regulatory, and scientific coverage across Asia, Europe, and North America.

IN
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India — Bengaluru HQ
Electronic City, Karnataka · Corporate Headquarters
  • Phase I–IV Clinical Operations
  • Bioequivalence Study Centre
  • Biometrics & Data Science
  • Regulatory Affairs (CDSCO · EMA)
  • Medical Writing & Quality
  • USFDA-Standard GCP Infrastructure
GB
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United Kingdom
London · European Operations & Sales Office
  • EMA Regulatory Strategy & Submissions
  • Phase II–IV Trial Co-management
  • MHRA Liaison & Compliance
  • European Site Network Access
  • UK-based Sponsor Engagement
  • EU Clinical Trial Regulation (CTR)
US
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USA — Sales Office
Boston, Massachusetts · Strategic Hub
  • USFDA Regulatory Submissions
  • Sponsor Business Development
  • NDA/ANDA Dossier Support
  • Phase II/III Trial Co-management
  • US-based Principal Contact
  • FDA Advisory Meeting Preparation
Ready to Partner with
Biosite Research?
Tell us about your study — our science team responds within 24 hours with a tailored feasibility assessment. No generic proposals. No junior handoffs.