We understand the complexities of planning and conducting a clinical trial.

A poorly planned trial can incur extra costs, delays in study completion, an increase in protocol amendments, and pose the risk of refusal of your IND, NDA, or MAA. Any trial should begin with a well-designed and written Clinical Study Protocol (CSP) to ensure the success of the rest of the study.

At Quanticate, our medical writers can support you with your protocol development. We are here to ensure that your CSP meets the highest standards of quality and compliance. In addition to the primary task of developing a protocol, we liaise with our expert statistical consultants to ensure your trial design is robust and efficient, so you don’t have to worry about generating your most important clinical trial document to get your trial off the ground.

Our Approach

Precision and Expertise

Our team of seasoned regulatory medical writers, medical experts, and research professionals combine their knowledge, experience, and passion to deliver comprehensive clinical trial protocol development services. We understand the critical importance of precision, compliance, and scientific integrity in the development of protocols that can withstand rigorous scrutiny from regulatory agencies and ethics committees.

Our Service Capabilities

Protocol Synopsis

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.

Protocol Elements Documents

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.

Clinical Trial/Study Protocol Writing

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

Protocol Conceptualization

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

Therapeutic Expertise

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.

Elaborate Protocol Synopsis per Template

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

Across Phases

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.

Protocol Amendments

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.

Schedule of Activities Tables

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 organized to meet your study objectives and endpoints.

Consistency and Quality Control

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.

Flexibility

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.

Choose Quanticate as your trusted partner in clinical trial protocol development. We are committed to delivering protocols that meet regulatory standards and bring innovative therapies to patients in need.

Contact us today to discuss how we can assist you in achieving your research goals across the full spectrum of clinical trials.

Request a Consultation

We are here to help ensure the success of your next project with a well-designed and written protocol.

Clinical Trial Protocol Development and Amendments