Our Medical and Scientific Writing team at Datapharm Australia specialises in creating the essential documents needed for the successful execution and reporting of clinical trials. With diverse backgrounds in science (PhD) and medicine (MBBS), our team brings a wealth of knowledge, planning, and writing experience to every project. We have developed standardised templates for key documents that align with current international guidelines, ensuring that these templates are regularly updated as guidelines evolve.

At Datapharm Australia, all work undergoes a rigorous multi-step quality control and review process, ensuring that every document we produce meets the highest professional standards.

Our Services

Medical and Scientific Writing for Clinical Trials

Clinical Trial Protocols

A well-structured protocol is essential for any clinical trial. With over 35 years of experience and including more than 400 trials, Datapharm Australia is well-equipped to design and write protocols for all phases of clinical research. Our medical writers collaborate closely with statisticians to ensure that sample sizes and methodologies are properly defined. We utilise the SPIRIT format as the standard template for all clinical study protocols.

Investigator Brochures (IBs)

Datapharm Australia’s medical and scientific writers have extensive experience in preparing Investigator Brochures according to ICH E6 guidelines. Our team includes qualified scientists who are skilled at interpreting and presenting preclinical technical data. We ensure that updates are made to the IB as new clinical data becomes available.

Participant Informed Consent Documents

We understand the importance of conveying complex medical and scientific information in an accessible and understandable way for non-specialists. Our team excels at crafting clear, concise, and informative participant consent documents, ensuring that all necessary details are communicated in simple language without losing important meaning. 

Clinical Trial Ethics Submissions

Our medical writing team oversees the preparation of all ethics committee submissions, with particular attention to sections involving the protocol, participant information, and materials intended for the lay reader. We ensure these documents meet the highest ethical and regulatory standards.

Clinical Study Reports

We utilise the ICH E3 document as the foundation for clinical study reports. However, we are also adept at producing shorter reports or custom reports tailored to client-specific templates. Our medical writers collaborate with statisticians to incorporate tables, figures, and statistical analysis in a clear, concise manner. We also produce a variety of other clinical trial reports, including DSMB reports, clinical trial summaries, and safety reports for regulatory authorities.

Safety Narratives for Clinical Trials and Regulatory Reporting

Datapharm Australia’s medical writing team regularly prepares safety narratives for serious adverse events (SAEs) during clinical trials. These narratives are included in Clinical Study Reports and are also submitted as part of regulatory reporting when required.

Manuscripts for Peer-Reviewed Publications

Our medical and scientific writers have significant experience in preparing and reviewing manuscripts for publication in peer-reviewed journals. We adhere strictly to the ICMJE guidelines for authorship, ensuring proper attribution based on the writer’s role in the study.

Abstracts, Posters, and Presentations

Our team is also skilled in preparing abstracts, posters, and presentations for scientific conferences, ensuring that key findings are effectively communicated to the broader research community.

At Datapharm Australia, we are committed to providing high-quality, compliant, and clear medical and scientific writing services that support the success of clinical trials and contribute to the advancement of medical research.