Planning and Protocol Design
Clinical Trial Protocol Design That Gets Approved and Enrols on Time
Most trial delays start at the design stage. Shen Clinical Services designs clinical trials around clear endpoints, realistic eligibility criteria and real Indian patient pools, then writes it to ICH E6(R3) and the new ICH M11 template, so regulators, ethics committees and sites can act on it without costly amendments.
ICH E6(R3)Current Good Clinical Practice
ICH M11Structured protocol template
ICH E9(R1)Estimands and statistics
India FeasibilityReal patient and site data
On this page
Design Elements
What Goes Into a Well-Designed Clinical Trial Protocol
Every study we design works through these decisions with your team, each grounded in the relevant ICH guideline:
| Design element | What we decide | Guideline |
|---|---|---|
| Objectives and endpoints | Primary and secondary endpoints that are clinically meaningful and measurable | ICH E8(R1) |
| Estimands | Exactly which treatment effect is estimated, and how intercurrent events are handled | ICH E9(R1) |
| Study design | Parallel, crossover or adaptive design, randomisation, blinding and choice of control | ICH E9, ICH E10 |
| Population and eligibility | Inclusion and exclusion criteria matched to real patient pools | ICH E8(R1) |
| Sample size and statistics | Power calculation, analysis populations and statistical analysis plan outline | ICH E9 |
| Safety monitoring | Adverse event definitions, reporting timelines and data monitoring committee needs | ICH E6(R3); NDCT Rules, 2019 |
| Protocol structure | Content and headings that reviewers expect | ICH M11; SPIRIT 2025 |
Quality by Design
Quality by Design: Fewer Amendments, Faster Enrolment
ICH E8(R1) and E6(R3) ask sponsors to build quality into the study design rather than inspect it in later. In practice, that means we:
- Identify the factors that are critical to quality and focus procedures on them
- Check eligibility criteria against real patient numbers at Indian sites before the design is final
- Cut visits and tests that add burden but no decision-making value
- Plan risk-proportionate monitoring from the start
- Have investigators and statisticians review the draft before submission
India Expertise
Protocol Development for Clinical Trials in India
An Indian trial design has to work for CDSCO, ethics committees and CTRI as well as your global programme:
| Requirement | Rule / timeline |
|---|---|
| Regulatory submission | Protocol filed with the Form CT-04 application to CDSCO (NDCT Rules, 2019) |
| CDSCO decision | Within 90 working days of application (Rule 22) |
| Ethics review | By an ethics committee registered with CDSCO |
| Informed consent | Must match the protocol and follow the Third Schedule, Table 3 |
| Trial registration | Key protocol details registered on CTRI before the first participant is enrolled |
| Amendments | Substantial changes need approval before they are implemented |
Our Process
Our Clinical Trial Design Process
STEP 01
Strategy Workshop
We agree the scientific question, target product profile and regulatory path with your clinical and regulatory teams.
STEP 02
Feasibility and Synopsis
We test the design against site and patient data, then write a protocol synopsis for early feedback.
STEP 03
Full Protocol and Statistics
Our medical writers and biostatisticians write the full protocol and outline the statistical analysis plan.
STEP 04
Review, Approval and Amendments
We support CDSCO and ethics committee review through our regulatory team, and manage any amendments.
Why Shen
Why Sponsors Choose Our Clinical Trial Design Services
Physician-Led Design
Clinicians shape endpoints and eligibility, so the protocol reflects how patients are actually treated.
Real Feasibility Data
Our site network tells us what Indian sites can recruit before you commit to a design.
One Integrated Team
Design, writing, statistics, approvals and trial conduct sit with one partner.
Therapeutic Depth
Experience in oncology, cardiovascular, dermatology and biosimilars.
What We Cover
Our Study Design and Protocol Development Services
Clinical development plans
Protocol synopsis
Full protocol writing
Protocol amendments
Endpoint and estimand strategy
Sample size calculation
Statistical analysis plan outline
Feasibility assessment
Adaptive and innovative designs
Protocol review and gap analysis
Informed consent alignment
Regulatory pre-submission advice
FAQs
Clinical Trial Protocol Design: Frequently Asked Questions
What is clinical trial protocol design?
Clinical trial protocol design is the process of deciding a study’s objectives, endpoints, population, treatments, assessments, safety monitoring and statistical analysis, then writing them into the protocol that investigators, ethics committees and regulators work from. Good design answers the scientific question with the fewest participants and the least burden.
What should a clinical trial protocol include?
ICH E6(R3) and the ICH M11 template expect a protocol to cover background and rationale, objectives and endpoints, study design, eligibility criteria, interventions, schedule of assessments, safety reporting, statistical methods, data handling, quality control and ethical considerations, including informed consent.
What is ICH M11?
ICH M11, the Clinical Electronic Structured Harmonised Protocol (CeSHarP), is a common protocol template with a technical specification for exchanging protocol content electronically. ICH adopted the final (Step 4) version in November 2025, and regulators are now implementing it.
What is an estimand and why does it matter?
An estimand, defined in ICH E9(R1), describes exactly what treatment effect a trial will estimate, including how events such as stopping treatment or taking rescue medication are handled. Agreeing estimands at the design stage aligns the endpoints, data collection and statistical analysis.
How do you reduce protocol amendments?
We test eligibility criteria and visit schedules against real patient pools and site capacity before the design is final, focus on the factors that are critical to quality as ICH E8(R1) recommends, and have investigators and statisticians review the draft. Most avoidable amendments come from unrealistic criteria and burdensome procedures.
Do protocols for trials in India need anything extra?
The protocol is submitted to CDSCO with the Form CT-04 application under the New Drugs and Clinical Trials Rules, 2019, and reviewed by a CDSCO-registered ethics committee. The informed consent form must match it and follow the Third Schedule, and its key details go into the CTRI registration.
Resource Spotlight
Protocol ready? See how we run clinical trials in India from approval to final report, or how our medical writing services turn it into consent forms, investigator brochures and clinical study reports.
Design Your Next Clinical Trial With Us
Starting from a concept? We will turn it into a protocol synopsis and design options.
Already have a draft? Ask for a protocol review before you submit.
+91 98968 89927 · info@shenclinicalservices.com · A 302, Urban Square, Sector-62, Gurugram, Haryana 122098
Sources: ICH efficacy guidelines E6(R3), E8(R1), E9(R1) and E10; ICH M11 (CeSHarP); SPIRIT 2025 Statement; New Drugs and Clinical Trials Rules, 2019 (CDSCO). General regulatory information, not legal advice.