Protocol and Report Writing

We offer protocol and report writing services to the animal health industry, ensuring exceptional quality that meets global regulatory standards. Our approach emphasises collaboration, communication, and timely delivery.

COMPREHENSIVE SUPPORT

Protocol and Report Writing

The VICH GCP Consultancy takes great pride in delivering protocols and reports of outstanding quality that meet the stringent requirements of our clients and regulatory authorities around the world.

Our services include: Study Synopsis, Protocols, Study Reports, Data Critique and Summaries, Publication Planning and Support.

A black and white cow with a yellow tag on its ear is standing behind a fence.

Study Synopsis

Preparing clear and concise summaries of the planned study, useful in engagement of potential Investigators, discussion with regulatory authorities and for trial clearance.

Protocols

Working closely with Sponsors to develop customised protocols that adhere to VICH GCP guidelines and regulatory requirements. We are happy to work with a Sponsor provided template or alternatively a template can be provided for client use. Peripheral study documents can also be written based on the final study protocol for use on the study, this can include: Investigator brochures, informed owner consent and training materials. Following protocol development, we help Sponsors to manage any changes to the protocol throughout the study, ensuring that they are properly documented, reviewed, and approved by the appropriate stakeholders.

Study Reports

We prepare comprehensive study reports that comply with VICH GCP guidelines and regulatory requirements. Working with third-party statisticians and key opinion leaders to ensure the statistical analysis is sound, the data are properly interpreted, and the results are accurately reported. The study report would include applicable appendices including, but not limited to: protocol, amendment, case inclusion, statistical reports, SAE reports etc.

Data Critique and Summaries:

Review of study data, identifying trends and potential issues to ensure the integrity of the data and the final study report validity. Review of data for discussion with authorities for case inclusion (e.g. blind case review with FDA), review of primary efficacy, deviations, AEs and concomitant medication administered.

Publication Planning and Support

Publication planning and support with the development of manuscripts for publication, ensuring compliance with ethical and legal requirements, and facilitating the dissemination of study results to the scientific community.

Ignite Innovation with a Great Protocol

Embrace Excellence with a Great Report

Every study the VICH GCP Consultancy performs, always has the end goal of a great report in mind. Whilst some clients prefer to use their own report template, the VICH GCP Consultancy can generate a report template for client use. Likewise if a client wishes to author the report, we are happy to support in the quality control and peer review or alternatively the entire process can be outsourced to the us.

Here is an example study summary, please note that due to the confidential nature of our industry, this study report summary is not based on an actual study but gives an idea of the level of detail produced in a VICH GCP compliance final study report.