Establishment of a Long-Term Medical Writing Partnership
In 2009, IMPACT (now part of Syner-G BioPharma Group) was contracted by a mid-size global pharmaceutical company to prepare 2 Phase 3 clinical study reports (CSRs) for a biologic agent for the treatment of Crohn’s disease. Following the successful completion of these 2 CSRs and the establishment of a highly positive collaborative relationship with the client, IMPACT was subsequently contracted over the next 2 years to prepare 9 additional CSRs, as well as a clinical study protocol and sections of a Pediatric Investigational Plan…
Given the highly successful working relationship that evolved over time, in 2012 the client established a Strategic Alliance Partnership with IMPACT. Ongoing work consists of the preparation of approximately 25 to 30 CSRs per year across numerous development programs.
As part of this partnership, IMPACT authors are considered an integral part of the client’s team, and our role encompasses all the roles traditionally held by the client’s internal medical writers. Therefore, in addition to authoring the CSRs and managing the review and quality control (QC) process, IMPACT authors also serve as the primary medical writing contact for the client’s project team, manage document timelines, and schedule roundtable or other team meetings.
In addition, IMPACT manages the compilation of CSR appendices and also performs electronic publishing of the CSR and appendices to ensure all documents are submission-ready.
To date, the work has encompassed a portfolio of 4 established products, as well as 8 new chemical entities, across a wide range of therapeutic areas including rheumatology and central nervous system disorders. Since the establishment of this partnership, IMPACT has also prepared a number of NDA/BLA components, including several Summaries of Clinical Efficacy and Safety (Modules 2.7.3 and 2.7.4) and 120-day Safety Updates.
Throughout our years of working closely with this client, we have continued to gain their trust, and our relationship has expanded to allow us to gain broader responsibilities beyond simply providing medical writing and QC services. Our IMPACT personnel have become a trusted extension of the client’s internal teams, and we have succeeded in making this integration seamless. As a result, a productive, long-term collaborative relationship has been forged.
“When it was time for our company to enter into a large, full scale strategic partnership I found it difficult to trust a large CRO with our submission-relevant CSRs. Based on previous experiences with IMPACT, I knew our CSRs would be in excellent hands and therefore we entered into a partnership that was specific for our medical writing deliverables. The writers at IMPACT are scientifically-oriented but are also operationally strong which is a unique combination that perfectly matches our internal medical writers. They have become a true extension of our internal team and feedback from our project teams has been absolutely glowing! I cannot thank them enough for the contributions they have provided over the last several years. Our partnership is and will continue to be a real success story!”
–Client’s Head of Global Medical Writing