Clinical research in India, done right
MyDoctor runs clinical studies in India on contract as your Clinical Research Coordinator, with Doctor-led, MD/PharmD Clinical Expert MyDoctor Staff. Or use the MyDoctor Clinical Research software for your own trials anywhere, or run academic research for PharmD, PhD, MD, nursing and every health course.
Three ways to work with MyDoctor
MyDoctor as your Clinical Research Coordinator in India
For sponsors and CROs in India and abroad who need a study run in India.
- Feasibility, site and investigator selection
- Ethics committee and CDSCO submissions, CTRI registration
- Participant recruitment from MyDoctor clinics, hospitals and families
- Coordinators at the site, visits, case forms and source documents
- Safety reporting on the Indian clock (24 hours, 14 days)
- Investigational product accountability, monitoring support and close-out
MyDoctor Clinical Research software
For anyone running a trial, anywhere: sponsors, CROs, hospitals, investigators and device companies.
- Studies, sites and every research role
- Participants, screening and e-consent with versions
- Visits and case forms (eCRF) you design, with source data checks
- Adverse events with reporting clocks
- Essential documents (trial master file), data queries, product accountability
- Finance: budget, site payments, participant reimbursement and study staff pay
- Audit trail of every change
Research for students and guides
PharmD Clinical Research, PhD research of any kind, MD and MS theses, nursing, physiotherapy, public health and all health and pharma courses.
- Project with the guide in the loop
- Protocol, ethics approval and CTRI where needed
- Data collection forms and participants
- Documents and the write-up
- College subscriptions for every student project
Every research role, with the right access
The company or institution responsible for the study
Runs the study for the sponsor
The doctor responsible for the study at a site
Doctors who see participants under the PI
Runs the study day to day at the site
Checks data against source documents and raises queries
Case forms, data cleaning and queries
Statistical plan and analysis
Adverse event review and reporting
Approvals, CTRI and submissions
Reviews and approves the study (read only, documents)
Receives, stores, dispenses and accounts for the study product
Budget, site payments, participant reimbursement and study staff pay
Independent audit (read only, full audit trail)
Guides a student project (PharmD, PhD, MD, nursing)
Runs an academic project under a guide
Built to the guidelines of the world
ICH E6(R3) Good Clinical Practice
The worldwide standard for running trials and keeping records.
New Drugs and Clinical Trials Rules, 2019 (India)
CDSCO approval, ethics committee registration, SAE reporting in 24 hours and the analysis in 14 days, compensation.
CTRI registration (India)
Every trial in India is registered on the Clinical Trials Registry of India before the first participant.
ICMR National Ethical Guidelines, 2017
Ethics for biomedical and health research with people in India, including academic research.
21 CFR Part 11, 50, 56, 312 and 812 (United States)
Electronic records and signatures, informed consent, IRBs, drugs and devices.
EU Clinical Trials Regulation 536/2014 and GDPR
For studies with sites or participants in Europe.
DPDP Act 2023 (India) and HIPAA (United States)
Privacy of participants' data.
Declaration of Helsinki
The ethical principles behind all research with people.
Each study is set up for the rules of its countries: reporting clocks, consent, ethics and registration. MyDoctor Clinical Research supports your quality system; the sponsor and investigators stay responsible for the study.
How it works
Tell us about the study and upload the protocol or synopsis and any other documents.
US$100, or ₹10,000 + GST in India (or the equivalent). Non-refundable.
MD/PharmD Clinical Expert MyDoctor Staff review the documents, usually within 5 working days.
If the study suits, we set up a meeting and send a written quote based on its complexity and the number of participants.
Apply with your protocol
Review fee: $150 $100 outside India, or ₹15,000 ₹10,000 + 18% GST in India. Non-refundable. The study cost is quoted after the review.
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