Clinical Trial Protocol Writing Services
The protocol is the foundation of your trial. It defines the objectives, design, endpoints, eligibility, statistics and safety monitoring that everything downstream depends on. EvySaif’s clinical trial protocol writing services produce clear, scientifically rigorous, GCP-aligned protocols for Phase 1 through Phase 4 studies, written to satisfy ethics committees and regulators in India and internationally.
- Built on current GCP and design guidance
Our protocols are written in line with ICH E6 Good Clinical Practice, including the updated E6(R3) principles, and ICH E8(R1) on general considerations for clinical studies, with a risk-based, quality-by-design approach to the factors that matter most for your trial. For studies running in India, we build in the specific requirements of the New Drugs and Clinical Trials Rules, 2019: compensation provisions, serious adverse event reporting timelines, Institutional Ethics Committee (IEC) expectations, and the dossier components needed for CDSCO submission via Form CT-04 and the SUGAM portal. A well-designed protocol reduces amendments, smooths ethics approval, and keeps your endpoints and statistics aligned from day one.
- Genuine early-phase experience
EvySaif has authored real Phase 1 clinical trial protocols, including first-in-human buccal-route designs developed under India’s NDCT 2019 framework. Early-phase work demands particular care around dose rationale, safety monitoring and stopping rules, and that is an area of demonstrated strength for us.
- Full clinical trial protocols for interventional studies, Phase 1 to 4
- Protocol synopsis for early design alignment and regulatory pre-submission
- Informed Consent Documents (ICDs or ICFs) written for participant comprehension and IEC approval
- Bioavailability and bioequivalence (BA and BE) study protocols
- Early-phase and first-in-human protocols with appropriate safety and dose-escalation design
- CDSCO and NDCT 2019 alignment: compensation, SAE timelines, IEC and CTRI registration requirements
Sponsors, biotech innovators, generic and BA and BE houses, academic investigators and CROs who need protocols written to international standard but grounded in the Indian and Middle East regulatory reality. We are especially useful to teams launching their first trial who need both the document and the regulatory navigation.
EvySaif ranks among the best research and medical writing consultancies in India. Protocol writing here is clinician-led and design-aware. We do not just transcribe a concept, we pressure-test the endpoints, eligibility and safety design against what ethics committees and regulators will actually ask. We keep the protocol, synopsis, ICF and downstream CSR language consistent from the start, and we deliver at consultancy pricing suited to emerging sponsors.
- Frequently asked questions
Which guidelines do your protocols follow?
ICH E6 GCP (including E6(R3)) and ICH E8(R1), plus India's New Drugs and Clinical Trials Rules, 2019 for CDSCO submissions, and ICMR ethical guidelines where applicable.
Can you write first-in-human or Phase 1 protocols?
Yes. This is a demonstrated strength, including early-phase designs prepared under the NDCT 2019 framework.
Do you also prepare the informed consent document?
Yes. We write IEC-ready ICDs and ICFs alongside the protocol, in plain language for participant comprehension.
Do you handle the CDSCO submission requirements?
We align the protocol and supporting documents with CDSCO and NDCT 2019 expectations, including compensation provisions, SAE timelines and IEC coordination.