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Drafting a Clinical Study Protocol – An Overview

In the last few years, the importance of clinical trials has become increasingly apparent. Unfortunately, in our modern, global community, COVID-19 may not be our last pandemic. Moving forward, it is vital we pinpoint new ways of ensuring their accuracy, legitimacy, and efficacy. Clinical trials are a vital function of Life Sciences, and new requirements to increase diversity as well as perform them remotely need a great deal of expertise, focus, and planning. In this first of a two-part series, we will outline the foundational needs related to clinical protocol. In the second installment, we will then discuss and highlight the implication of the evolving environment including diversity and decentralized clinical trials.

Fundamentally, trial investigators need to describe the objectives, design, methodology, statistical considerations, and organization of a trial while ensuring adherence to stringent regulatory guidelines. This is essentially a clinical study protocol.

✔ What is a clinical study
✔ When is a clinical study protocol drafted?✔ How is a clinical study protocol drafted?
✔ Why is a clinical study protocol important?✔ Who drafts a clinical study protocol?✔ What are the constituents of a clinical study protocol as per ICH-GCP?

A clinical study protocol is an essential parameter for trial investigators, enabling them to tick all the necessary boxes for a successful clinical trial. It is the first document that is drafted when designing and planning a clinical trial. All related and involved documents, templates and forms, digital interventions, etc. are in alignment with the protocol. Moreover, a clinical study protocol also enables everyone working on a trial to adhere to stringent regulatory guidelines. This is critical to the success of the trial, which is why multiple parties help to draft a protocol. The spotlight shines bright on clinical trials right now. As such, it is paramount that the investigators get everything right.

High-level overview of how to draft a clinical study protocol

There are several steps involved in the design and development of a protocol. A high-level, simplified representation is illustrated in the diagram below:

Thought leadership

Drafting a Clinical Study Protocol – An Overview

Amongst the various parameters, contributing towards delivering successful clinical trials, a well-defined clinical study protocol is an essential one.

Capgemini Invent’s clinical trial capabilities

At Capgemini Invent, we have over 50 years of experience supporting Life Sciences organizations with vital transformations. We have a long history of designing clinical trials and subsequently drafting them as clinical study protocols. Supported by our in-house smart trial platform, our experts can help develop protocols that are detailed, patient-centric, operationally feasible, well-rounded, and in compliance with the applicable regulatory and other binding requirements.

And for further enquires, start a conversation with one of our experts below.

Contact our experts

Broderick Jones

Global Head of Life Science & Med Tech, Capgemini Invent
Broderick brings extensive Life Science and Healthcare experience to each client engagement with the goal of driving top-line growth and building capabilities for ongoing commercial success and cost management. His track record of developing high quality business strategies and transformation plans has driven unparalleled customer experience and internal operational excellence globally.

Vincent Mittoux

Engagement Director at Capgemini

Kamalika Chattopadhyay

Senior Manager at Capgemini Invent

Poonam Shirke

Director Life Sciences at Capgemini Invent

Suday Karkera

Head of Life Sciences at Capgemini Invent India
Suday is a Life Sciences professional with over 20 years of experience in strategy, consulting, business development and marketing research with knowledge of Indian and global markets.