Investigator's Brochure (IB) Medical Writing
What is Investigator’s Brochure?
Investigator’s brochure (IB) is a document that has the essential preclinical and clinical information relating to the investigational product to investigators, researchers, regulatory authorities and also the human research ethics committee. It’s main objective is to provide adequate detailed information about the product’s properties, safety profile, pharmacology, human dose calculations, and also clinical use.
Obatica’s Investigator’s Brochure Medical Writing Services
Obatica believes that a high quality clinical study protocol will need multi disciplinary inputs and reviews. That is why Obatica’s medical writing team consist of medical writer that are complemented with in-house scientist, medical monitor, medical director and QA. All having real industry clinical trial experience from major site/research centre and/or industry providing their multi dimension inputs.
Low quality clinical study protocol can lead to “avoidable” protocol amendments. One research suggests that the median cost for a major protocol amendment is around US$141,000 for a phase II protocol and $535,000 for a phase III protocol. High quality clinical study protocol will eliminate or reduce unnecessary amendments by pre-empting and incorporating scenarios into the initial protocol design.
Valuable input from experienced medical monitor and clinical trial experts can potentially safe the overall cost of the study by eliminating, reordering, or maximising the treatment plans.
Obatica’s medical writing team are experienced in developing a high quality clinical study protocol that would suit your study needs.
Book in for your free consult here to learn more about our medical writing services
Obatica’s Medical Writing Services:
- Protocol review, writing and development (full protocol development)
- Participant information consent sheet/form (ICF)
- Investigator’s Brochure creation
- Clinical study reports creation
- Medical writing for abstract and manuscript
- Support and assistance with conference/journal submission
What customer says about Obatica’s Medical Writing Services
Obatica recently performed two medical writing projects for a clinical-stage Biotechnology company. The client has a very ambitious timeline which Obatica is able to handle it nicely. Here is what ourclient has to say.
“Obatica is one of the best medical writers that we have worked with. We were impressed not only by the high quality of their work but also their ability to deliver the protocols under very ambitious timelines, customer-orientated attitude and overall value. We look forward to working with Obatica again on our future medical writing projects.”
Kon Yew Kwek, BMBCh, DPhil. Vice President, Clinical Development, Hummingbird Bioscience u