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European Pharmaceutical Contractor

Re-Writing the Rule Book

Outsourcing regulatory writing poses the risk of uncontrolled staff turnover and sub-optimal use of in-house resources. In spite of the challenges, more companies are opting to outsource medical writing and harness the flexible, cost-efficient benefits it brings.

High operating costs, thinning pipelines, requirements for lower prices and increased regulatory burden have all contributed to a challenging period for the pharmaceutical industry over the past 10 years. As a result, companies have been required to adopt new visions and processes and develop a fundamentally new approach to the way they operate their businesses. This increasingly demanding landscape has led to a drive to reduce operational costs by outsourcing some activities to providers of specialist services such as pharmacovigilance procedures, quality assurance and medical writing.

The outsourcing of medical writing activities associated with clinical trials has seen marked growth over recent years, with demand for these services rising as companies look for faster and more cost-efficient ways to meet deadlines and take new drugs to market. In addition, as the regulatory setting becomes more demanding, the level of documentation required on the safety and efficacy of new drugs is increasing. In the current climate, high-quality medical writing can facilitate the review process by enhancing document clarity and the relevance of content to its purpose. As a result, highquality medical writing is essential both in advance of a drug gaining regulatory approval and during the course of its delivery to market.

Medical writing activities associated with clinical research that can be outsourced include the preparation of clinical trial documents, such as protocols, investigator brochures, patient information sheets, patient diaries, safety narratives, clinical study reports, informed consent forms and regulatory submission files. Choosing an external source for the development of these materials can improve both quality and speed of delivery, providing better organised information to regulatory authorities faster and as a result, improving patient care.

The Benefits of Outsourcing

Outsourcing to companies that have staff with medical backgrounds and in-depth knowledge of industry regulations not only increases the speed of work, but enables pharmaceutical companies to meet deadlines while maintaining the highest levels of quality. In addition, for many pharmaceutical companies that do not need to produce a large volume of regulatory submissions, maintaining an expert medical writing team can be unrealistic and a drain on resources. Outsourcing enables the company to uphold the level of quality required without having to sustain a full-time writing workforce, providing access to the necessary expertise in a cost-effective manner.

For many pharmaceutical companies, high mobilisation rates pose a big challenge to the development and maintenance of a medical writing department. Further, the bulk of medical writing tends to be skewed towards developmental milestones and either end of individual clinical studies. This means that medical writing departments may have idle staff waiting for work, which causes unnecessary expenditure. To overcome these issues, companies dedicated to medical writing, staffed by highly-educated technical writers with medical experience, can offer flexible access to services at specific times and be reactive to the large volumes of writing that are required at the beginning and end of clinical studies.

Challenges Associated with Outsourcing

The advantages and disadvantages of outsourcing medical writing are always subject to close scrutiny; however, effectiveness will always be measured on its ability to reduce costs and expedite developmental timelines while maintaining quality. To ensure that outsourcing any activity is worthwhile, it should be approached cautiously with a full understanding of the potential risks, in order to minimise challenges and maximise success.

The most common concerns associated with outsourcing writing activity are the potential for miscommunication or misinterpretation of the source data, decentralised control, process inefficiencies, loss of productivity during transmission of knowledge to the service provider, uncontrolled staff turnover and sub-optimal use of in-house resources. In order to overcome these perceived risks a robust training and management plan must be put into place at the outset of a partnership. This should ensure that the vendor is adequately trained in the clientís business and products, understands the scope of the project, is aware of deadlines, quality parameters and long-term strategic plans and works to the highest data security and compliance standards.

The level of communication between the client and vendor is also an important factor in a successful working relationship. Pharmaceutical companies need to ensure that their chosen partner has all the relevant information about a particular project. In addition, this communication should be continuous, with the vendor being updated about any changes or developments in the same way as any other member of the clinical team. This will help to eliminate the potential for inaccuracies and keep timelines to plan.

Choosing the Right Provider

Collaboration is fundamental to the development of complete and accurate clinical development and other documents. For the relationship to be collaborative and successful, several factors must be considered. It is imperative to make sure that the contracted company possesses the breadth of experience, knowledge and skills to meet the needs of the clientís clinical programme and its regulatory demands. In some circumstances it can be advantageous to contract separate regulatory and writing vendors to maximise the advantages of their specialist experience. Ensuring the service provider has established standard operating procedures to maintain confi dentiality, data security and quality of deliverables is essential. Prior knowledge of a therapy area is preferred to capture the nuances of the data but is not an essential requirement for experienced medical writers. In contrast, detailed experience of collating information and reporting data coherently, accurately and in required formats is essential to facilitate delivery of high-quality documents that are fundamental to the clinical development, regulatory approval and subsequent marketing of medicines.

Conclusion

The volume of medical writing necessary across the pharmaceutical industry has increased in recent years, despite global and regional strategies to harmonise documentation. In addition, the increasing demand to get new drugs to market faster and maximise patent life means that clinical trials must be delivered as efficiently as possible, and accompanying documentation during and after their completion produced with minimal delay. Resulting peaks and troughs in writing requirements may mean that it is impractical to have an in-house writing team and outsourcing is an efficient and costeffective alternative.

The decision to outsource medical writing requirements to expert vendors results in increased fl exibility and monetary benefi ts, while having the added advantage of enabling more money to be channelled into R&D activities. If outsourcing is carried out effectively, the benefi ts can be signifi cant, ranging from cost savings and fl exible access to expertise, to process improvements and the opportunity to work with an experienced and impartial knowledge source. By utilising the services of a reputable provider, companies can obtain quality, unbiased medical writing in a cost-effective manner, saving time and money at all stages of clinical development and helping to accelerate regulatory approvals and the delivery of new drugs to market.


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James Sawyer is CEO of Prism Ideas. Following a clinical career in general medicine and anaesthetics, James moved to the pharmaceutical industry in 1993, holding leadership positions in companies including Sanofi , AstraZeneca and Roche. Jamesís clinical development experience spans all phases of clinical research and he has published widely across a variety of therapeutic areas. He has driven regulatory interactions for many compounds and is the author of several expert reports fi led at European and North American Agencies. James founded Prism Ideas in 2001.
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