We craft concise and compelling protocol synopses that provide a clear overview of your clinical trial's objectives, methodologies, and key elements. This serves as a valuable tool for internal decision-making and regulatory submissions.

Our experts create comprehensive Protocol Elements Documents (PED) that outline all essential components of your clinical trial, ensuring that every detail is meticulously planned and documented.

We excel at writing clinical trial protocols according to TransCelerate’s Common Protocol Template (CPT), offering a harmonised and streamlined approach to the format and content, while adhering to regional and global regulatory requirements.

Our team assists you in conceptualising your protocol, ensuring that your study design aligns with your research objectives and is scientifically robust.

With extensive experience across various therapeutic areas and indications, our medical writers are equipped to develop protocols for a wide range of medical conditions, ensuring that your study is grounded in clinical expertise, the latest scientific knowledge, and best practices.

We create detailed protocol synopses that follow the CPT or sponsor templates, providing comprehensive insights into the study's design, objectives, and methodologies.

From early, small-scale Phase 1 studies to late-stage, large scale, Phase 3 studies or post marketing/Phase 4 studies, we have the expertise to develop protocols that align with the specific requirements of each phase.

We write protocol amendments and provide a clear summary of changes, ensuring that modifications are accurately documented across all the applicable sections and compliant with regulatory guidelines.

We create comprehensive Schedule of Activities (SOA) tables, outlining the sequence of events, assessments, and procedures for your clinical trial. The detailed time and event schedules prepared for your study will help you ensure that all activities are well-planned and organised to meet your study objectives and endpoints.

We maintain strict consistency between the protocol synopsis and the protocol body, as well as among different sections of the protocol, ensuring a cohesive and error-free document.

As per the requirement of the project, we are flexible in preparing additional drafts of the protocol to accommodate any late inputs or recommendations from sponsor or regulators.