Developing Clinical Trial Recruitment Materials

Introduction

For around 5 years, Alchemy partnered with a global communications group to provide regulatory writing support for an ambitious oncology platform study. Our team was involved from the protocol development stage through to authoring multiple Clinical Study Reports (CSRs) and associated errata.

This large, multi-year programme required exceptional organisation, scientific understanding, and cross-functional collaboration. By maintaining continuity of medical writing leads throughout, Alchemy ensured consistency, efficiency, and clarity across all study documents.

We continue to support our client with new projects.

Client

A global communications group working with a Top 10 pharmaceutical company.

Challenge

We authored several protocols from scratch and led authoring activities for several program-wide protocol amendments, amending up to 11 protocols each time.
We authored 10 modular CSRs, an observational CSR, an over‑arching core CSR, and 5 associated errata documents.
Our involvement with the programme spanned around 5 years, beginning with the development of new modular protocols and subsequent amendments, which allowed us to build deep familiarity with the programme and client team.
The modular CSRs covered different combination treatments, the observational CSR followed a cohort of patients for survival who did not receive study treatment, and the core CSR summarised data across the programme.
Coordinating feedback from dozens of stakeholders worldwide, we helped ensure consistency in level of detail, messaging, and formatting across documents.
As pharma team turnover occurred among clinicians, statisticians, and project leads over time, Alchemy provided valuable continuity and context, helping to explain historical decisions and maintain alignment.
Key challenges included ensuring stylistic and procedural consistency across multiple CSRs, integrating evolving template updates, and managing the impact of late database corrections and protocol amendments.
We worked in accordance with client SOPs and within their document management system to coordinate authoring, review, and version control efficiently.

Approach

To manage a programme of this scale effectively, Alchemy established a clear, long‑term framework for planning, communication, and document control.

This is how we did it:

Developed a multi-year timeline, mapping expected database locks dates, output delivery dates, and CSR authoring order.
Built detailed annual timelines incorporating team availability, key milestones, and non-overlapping review periods across multiple concurrent documents.
Held regular client meetings to track progress, discuss database updates, and confirm whether upcoming CSRs would be full or abbreviated.
Front-loaded early sections and shell tables to allow rapid drafting once final outputs became available.
Attended clinical input meetings ahead of authoring complete drafts to ensure alignment with the study team on key messages.
Implemented client feedback consistently across CSRs to harmonise structure, style, and content.
Managed template updates mid-project, reviewing changes alongside earlier CSRs to apply sensible, justified updates while maintaining consistency.
Supported the management of database corrections and late-breaking issues through CSR errata, advising the client on optimal approaches to capture and communicate updates.
For the observational CSR, applied rigorous naming conventions and data clarity to differentiate complex sub-group analyses and ensure precision in interpretation.
Coordinated document review and approval through the client’s document management system, ensuring version control and clear audit trails.

Result

We delivered high-quality, internally consistent CSRs and associated documents, often with few findings during quality control review.
We maintained trusted involvement from the project’s inception through to completion, fostering strong relationships with the end client’s global team.
We provided valuable continuity and institutional knowledge across years of work, enabling efficient resolution of issues and preservation of a consistent authoring approach.
We demonstrated exceptional organisation, agility, technical expertise, and communication, contributing to the smooth delivery of a complex, multi-year regulatory writing programme.

Summary

Alchemy’s sustained involvement in this oncology platform study exemplifies our ability to manage large-scale, multi-year regulatory writing programmes with precision and consistency. Our proactive planning, adaptability, and commitment to quality ensured the successful delivery of more than a dozen complex regulatory documents, reinforcing our reputation as a trusted, long-term partner in medical writing.