Clinical Trial Protocols

A clinical trial protocol outlines the study design and objectives, mapping out assessments and operational details to support participant safety, site execution, and ultimately, the validity of your data. A protocol that is ambiguous or overly complex can lead to costly delays, protocol deviations, and amendments that waste time and resources.

We can help you avoid these pitfalls by providing expert regulatory writing support to draft high-quality, thoughtfully constructed protocols and amendments, whether you’re initiating a first-in-human dose-finding study or gearing up for a pivotal Phase 3 trial.

Strategic, Compliant, and Readable Protocols

Our regulatory writing team supports you throughout the protocol development process.

Protocol Authoring from Concept to Finalization

At Med Communications, we understand that team alignment on a solid protocol concept is key to facilitating protocol authoring, review, and approval. We work closely with your safety, regulatory, biostatistics, and clinical operations teams to refine your study concept and expand that outline into a structured, regulatory-ready protocol. Our team works to bring clarity to complex designs and ensure alignment across functional areas, all while keeping participant safety and data integrity at the forefront. Med Communications’ writers are well-versed in ICH E6(R3), ICH E8(R1), and the TransCelerate and draft ICH M11 protocol templates. We are also familiar with the requirements for submitting protocols to the EMA’s Clinical Trials Information System (CTIS) platform; our writers tailor each protocol to fit the study design while anticipating regulatory agency expectations.

Protocol Amendments Without the Chaos

Regardless of how well written a protocol is, sometimes amendments are unavoidable. Whether the amendment is as minor as clarifying eligibility criteria or as substantial as adding a new treatment period, our expert writers will solicit input from all functional areas, assess the full scope of the changes, and incorporate revisions efficiently, all while tracking the edits in a detailed Summary of Changes. Their familiarity with ICH guidelines, company templates, and regulatory expectations ensures the amendment meets high-quality standards and avoids unnecessary rework.

Harmonization with Other Clinical and Regulatory Documents

We ensure that your protocol and protocol amendment are consistent with your template, Investigator’s Brochure (IB), Informed Consent Form (ICF), and planned statistical analyses. Consistency across documents reduces the risk of regulatory questions and misinterpretation at study sites. If you need help updating your ICF, we can do that in parallel with your protocol amendment. This proactive approach reduces the risk of discrepancies and helps keep your clinical study – and clinical development program – on track.

Writing Support for Protocol Synopses and Public Disclosure

We can also develop plain language protocol synopses for regulatory submissions and public disclosures (eg, CTIS and clinicaltrials.gov postings), confirming that they accurately reflect the protocol content while meeting format, readability, and regulatory requirements.

Benefits of Working with Our Regulatory Writing Experts

Regulatory Insight You Can Trust

Our regulatory writing team includes PharmDs and PhDs with extensive industry experience supporting INDs, CTAs, and global development programs. We stay current with evolving ICH guidelines and regulatory expectations across the US, EU, and other regions, and we proactively flag potential concerns before they become issues.

Experience with Complex Study Designs

Med Communications’ expert medical writers understand the complexities of modern clinical trial protocol designs. Whether your team is creating a master protocol, developing an umbrella or basket study, or mapping out an adaptive study design, our writers can help; we are well versed in traditional study designs as well as innovative and flexible approaches. Our writers bring structure to complexity and ensure the protocol tells a cohesive story that supports participant safety, regulatory success, and operational execution.

Efficient, Collaborative Process

We understand the internal pressures your team faces from tight timelines, cross-functional alignment, complex internal approval processes, and shifting priorities. Our writers are skilled facilitators who can lead team meetings, manage timelines, and consolidate feedback across functional areas to get your protocol or amendment finalized.

Flexible Support Models

Whether you need start-to-finish authoring of a single document, extended support for your internal team, or a rapid turnaround on an urgent amendment, we have engagement models that meet your needs. We integrate seamlessly with your existing processes and tools, or we can bring our own best practices to help streamline your workflow.

Therapeutic Area Expertise

From oncology to rare disease, our writers bring scientific fluency and therapeutic area knowledge that enables us to contribute meaningfully to protocol strategy – not just document formatting. We ask questions, spot inconsistencies, and help ensure the protocol reflects a scientifically sound, feasible, and ethical approach to your study.

When to Bring Us In

The earlier we’re involved, the more value we can add. Engaging our team during protocol concept development helps identify risks, clarify objectives, and align functional areas before the study design is locked in. However, we’re equally experienced with jumping into in-progress projects that need expert rescue or acceleration.