Case Studies

A clinical research client from a biopharmaceutical company had employed a large contract research organisation to write a protocol for a landmark, international, phase 3 clinical trial. The client was unhappy with the quality of the protocol (she could see costly amendments being required) and she was also concerned that it would not meet the regulatory requirements of some of the study countries. Having recently seen a medical writer from ProScribe give an excellent presentation on protocol writing, the client approached ProScribe about revising the protocol. Read more

A scientific communications client in a biopharmaceutical company had contracted a freelance medical writer to help authors prepare a manuscript summarising important clinical findings from a pivotal, phase 3, clinical trial. Neither the authors nor the client were impressed by the quality or speed of his work. The client was also concerned about the limited interaction between the freelancer and the authors - was there a risk that the freelancer not complying with GPP2? Given these concerns, the client realised a specialist medical writing group was needed. She approached ProScribe to work with the authors, in compliance with GPP2, to rewrite the manuscript…speed was needed as several publication plan milestones had been missed. Read more

A health outcomes client from a biopharmaceutical company had entrusted an external study investigator to prepare a slide and a poster presentation for a prestigious international conference. Despite assurances everything was under control, only one week before the conference, the study investigator informed the client that she had underestimated the time required to prepare the presentations and “things were not going well”. Needing assistance fast, the client turned to ProScribe for help. Read more

A medical affairs client from a specialist pharmaceutical company wanted to develop an accredited continuing medical education (CME) program, but had limited time and experience in developing and gaining accreditation for CME programs. Wanting to work with “proper” medical writers who had scientific expertise and an ability to work with key opinion leaders, the client asked ProScribe to prepare and manage the CME program. Read more

A clinical research client from a device company had contracted a large contract research organisation to analyse the data and write a clinical study report (CSR) of a pivotal, phase 3, clinical trial. Despite the data analysis and CSR being completed on time, the client realised that the CSR had numerous errors (especially inconsistencies between sections, even for safety data!), the writing quality was unlikely to impress regulators, and the structure and format of the CSR did not adhere to the client’s in-house style guide. Disappointed and wanting the CSR to be rewritten and put through a rigorous quality control process, the client turned to ProScribe for help. Read more

A regulatory client from a biopharmaceutical company recognised that several of their staff lacked experience and expertise in writing clinical study reports (CSRs). The client knew his senior internal CSR reviewers were becoming increasingly frustrated by the quality of the CSRs. Further, the numerous feedback cycles were causing key CSR milestone dates to be missed. To counteract this situation (and to placate internal senior staff), the client approached ProScribe to develop a specific course on writing CSRs. Read more

A medical affairs client from a biopharmaceutical company required a high quality slide presentation summarising the findings from a published study on the treatment of patients with a chronic disease. He had limited time to reach a primary care audience (there was no time to conduct a Phase 4 clinical trial!) and would be using the slides to help educate this audience at evening seminars in major cities. The client remained concerned, however, that not all primary care physicians would be able to attend these seminars and too many were unlikely to be aware of the original peer-reviewed publication, which focused on a specialist audience. The client approached ProScribe to help him prepare the slide presentation. Read more

A scientific communications client from a device company in the US noticed that her authors from the Asia-Pacific region were having difficulty responding to reviewers’ comments on a manuscript submitted to a well-regarded journal. Having read ProScribe’s international peer-reviewed publication on how to respond to reviewers’ comments, she approached ProScribe for assistance. ProScribe noticed that one of the reviewers, who was overly critical of the manuscript, appeared to have misunderstood the purpose of the study. Read more