Investigator’s Brochures
Our experienced team of medical writers can save you time by preparing your Investigator’s Brochures. If you are seeking a concise, objective, and impartial summary of your clinical and nonclinical data, you have come to the right place.
The importance of Investigator’s Brochures
As the name suggests, Investigator’s Brochures give Investigators and ethics committees an overview of the entire development program relating to a trial drug.
The document needs to contain all the information relating to the drug’s dosage, regimen and administration, as well as the safety monitoring procedures. The aim is to produce a well-written, concise piece of work containing precise details, both clinical and non-clinical, relating to the current stage of development.
A well-written Investigator's Brochure can save time, particularly for those reviewing the data, and shape future updates.
What should be included in an Investigator’s Brochures
Section 7 of International Council Harmonisation E6: Guideline for Good Clinical Practice (GCP) is an internationally recognised, ethical, and scientific quality standard for conducting and reporting drug trials.
GCP states that an Investigator’s Brochure should be produced when a drug’s development reaches the time to conduct the first clinical study in humans. Regarded as a living document, the brochure requires updates as work progresses and new information becomes available.
Updates should be made at least once a year, including new data on the characteristics of the new product, especially anything relating to safety. This should lead to a further assessment of the benefits and risks.
Regarding the structure of the Investigator’s Brochure the highest level sections should include:
- Summary
- Introduction
- Physical, chemical, and pharmaceutical properties and formulation
- Non-clinical studies
- Effects in humans
- Summary of data and guidance for the Investigator
Why choose Bham Pharma?
Our team of professional medical writers understand that the information contained in the Investigator’s Brochure should make it easier for the reader to make an objective assessment of the viability of the proposed trial.
The main challenge when producing a brochure is to create a simple, concise, and focused document. Our writers have the skills and experience to find a presentation style that strikes the right balance between thoroughness and readability.
During the course of the drug development programme, the brochure will need to be amended and updated, but our writer will strive to keep the maximum length within 100 pages.
Here at Bham Pharma, we have many years of experience in assisting our clients to produce clear and concise Investigator’s Brochures for regulators and other stakeholders.
The process of writing an Investigator’s Brochure
Our team of professional medical writers understand the clinical development process and the need for a strict timeline. By working together with our clients, we can plan and produce Investigator’s Brochures in line with their clinical programme.
One of the key considerations is the need for conciseness, which can be challenging when supplied with lengthy contributions from the clinical team. The writer’s job is to reduce the length of the reports, while retaining the key findings. The focus should be on making the review process easier for the intended audience.
When making updates, the aim is not to increase the length of the brochure. This means that when new information is added, existing content needs to be edited down. The first Investigator’s Brochure is based upon non-clinical information, with each update adding more clinical data as the programme develops.
Need help with your Investigator’s Brochures?
Our friendly team of medical writers can support you in your new product development. Contact Bham Pharma today to find out how we can assist you.