Clear and concise study documentation.
About Medical Writing
Our vastly experienced Team has managed many high-quality clinical trial projects covering a vast array of medicine and medical device assets. We provide analysis and medical writing services for both investigator initiated and industry-sponsored clinical trials. Highly qualified to interpret quality, non-clinical and clinical data to effectively present information in a clear and concise manner, our team can design and write investigators brochures, clinical protocols and investigational plans for all clinical trial phases and work closely with you to ensure suitable methodology and sample sizes. Our writers can also develop crucial documents that ensure full and informed consent, with potential participants provided with a clear and unbiased understanding of the clinical trial, including its purpose, benefits, safety protocols and risk.
In more detail
Investigator Brochures (IB)
Providing essential information according to ICH guidelines that captures key data intended to support ethical and regulatory approval for your study
Clinical Trial Protocols
Designing and writing protocols for all clinical trial phases, in close collaboration with you
Participant Information Consent (PIC)
Providing participants with clear and unbiased information, creating the opportunity for full, informed consent
Clinical Study Reports
In accordance with ICH guideline E3, the study report includes clinical trial summaries, safety reports, pharmacokinetic and pharmacodynamic analyses