Who we are – Our Medical and Scientific Writing team specialises in producing the necessary documents needed to successfully conduct and report on clinical trials. All our team members have qualified for the prestigious CMPP, awarded by the International Society for Medical Publication Professionals (ISMPP), attesting to their capability and expertise in this field. They come from diverse scientific (PhD) and medical (MBBS) backgrounds and bring a multitude of planning and writing skills to every project. Datapharm medical writers have prepared standardised templates for all major documents according to current international guidelines which will be reviewed as international guidelines change.
All work undertaken by Datapharm Medical and Scientific Writers undergoes a multi-step quality control and review process ensuring professional documents of the highest quality are released to our clients.
Medical and Scientific Writing for Clinical Trials
Clinical Trial Protocols
Every clinical trial needs a protocol by which to operate. Datapharm has over 25 years of experience and over 350 trials to draw on, placing the medical writing team in an ideal position to design and write protocols for all Phases of clinical research. They work closely with the statisticians to ensure appropriate sample size and methodology. Datapharm medical writers currently use the SPIRIT format as the template for all clinical study protocols.
Datapharm medical and scientific writers have compiled many IBs to ICH E6 guidelines using information provided by sponsors. Some of our team are qualified scientists with a wide range of experience in the interpretation and presentation of preclinical technical data. Updating of editions can be completed as clinical information becomes available.
Patient informed consent documents for Clinical Trials
We recognise the importance being able to convey complex, technical and medical information to lay people. Producing information documents and advertising material for potential participants requires particular skill, giving all the necessary details in simple language without losing meaning or sounding patronising. One of our team members has authored over 100 articles for a medical encyclopaedia for the general public, a skill which has found a natural home creating PIC documents.
Clinical Trial Ethics Submissions
All ethics committee submissions prepared by Datapharm are overseen by our medical writing team, particularly those parts requiring descriptions of the protocol and patient information and any material aimed at the lay reader.
Clinical Trial Reports
The ICH E3 document is used as the template for the clinical trial report however our team of medical and scientific writers can produce short reports or reports to client templates when requested. The medical writers work closely with the statisticians to incorporate all tables and figures according to the statistical analysis plan and to write appropriate text. Other types of clinical trial reports produced by Datapharm medical writers include DSMB reports, clinical trial summaries and safety reports for regulatory authorities.
Safety narratives for Clinical Trials and regulatory reporting
Our medical writing team regularly produce safety narratives for serious adverse events occurring during clinical trials. These are included in the Clinical Trial Report and, where necessary, form part of the regulatory reporting process.
Manuscripts for peer-reviewed publications
Our medical and scientific writers have substantial experience in preparing and reviewing manuscripts for publication. Attribution of authorship or contributorship depends on the role of the writer in the conduct of study as determined by the ICMJE guidelines which are strictly followed.
Abstracts, posters and presentations
Preparation of abstracts, posters and presentations all form part of the Datapharm Medical and Scientific Writer’s skill-set.