Increasing rates of patent expiration are driving the need for a higher number of successful clinical trials. Medical writing is a key support activity for a successful clinical trial. It involves creation of medical documents as an integral part of clinical research. With the inclusion of more diverse pharma products, there is a need for medical writing even for non-core activities such as report writing, which is another driving force for the industry. Most of the major pharmaceutical companies tend to outsource their clinical data management to qualified medical writing service providers.
A Key Support Activity for Clinical Research
Medical writing involves creating different types of scientific documents that include research-related and regulatory documents, publication articles such as journal manuscripts and abstracts, drug or disease-related promotional and educational literature, content for healthcare websites, news articles, or health-related magazines. Documents of different complexity levels are produced at various phases of clinical development. Usually, during the initial phases, the documents are less complex; they increase in complexity during the later phases of a clinical trial.
Growing Demand for Outsourcing
Medical writing outsourcing activities have been observed in the pharmaceutical industry since the last two decades. The demand for medical writing service providers is constant throughout the phases of clinical research. Such activities begin early, with the drafting of the clinical development plan, and continue throughout the phases of clinical trials and finally in preparing the common technical document and answering regulator queries.
The increased focus on pharmacovigilance and transparency in clinical data sharing is further increasing the demand for medical writing services. It is now believed that medical writers should be involved in the clinical research process from the initial stages itself to maintain the quality of data documentation throughout the process.
The key challenge, however, is to find a professional medical writing service provider with experience and capabilities, and then manage the outsourcing process such that the clinical research team gets the support from the service provider as and when required.
Making Outsourcing a Success
Successful outsourcing of medical writing requires selecting medical writing service providers who not only understand the criticality of clinical documents, but who can also coordinate well and challenge the clinical research team to present well-argued and clear clinical research outcomes. The medical writing service provider should be integrated well with the clinical research and development team for a successful outsourcing program. Some of the key suppliers of medical writing services operating in the industry include PAREXEL, CACTUS Communications, Freyr Solutions, and Trilogy Writing & Consulting GmbH.
Benefits of Outsourcing
Pharma companies can reduce their personnel requirements by cutting down their cost of recruitment, training and retention by outsourcing scientific and clinical writing projects. Clinical/medical writing companies offer greater flexibility to those who can’t afford to maintain exclusive writing personnel/teams in-house. Depending on a company’s requirement, medical writing companies help reduce costs on staff and materials and improve organizational profits. By outsourcing medical writing, companies can better focus on their core activities.
With a professional medical writing team, a company doesn’t have to hire multiple people for writing, editing and abstract poster presentation. Every client has a different budget and a different level of content requirement. Most of the medical writing service providers offer customized writing services to satisfy these diverse client requirements.
Successful outsourcing of medical writing services requires medical writers who not only understand the requirements of each document but are also proficient coordinators within the organization who can collaborate with clinical research teams and other cross functional teams to communicate study requirements and outcomes in a clearer manner. The key to success lies in communicating frequently, integrating the writers with the clinical research team, and maintaining a long-term relationship that is mutually beneficial.