Regulatory Medical Writing Services- Strategic Enabler in Drug Development
Medical writing services team plays a significant role in ensuring error-free, high quality, timely submissions of marketing authorization application and help companies get the submission right the first time.
Why regulatory medical writing services?
Pharmaceutical companies have to spend an average of over 2.5 billion USD for getting a new drug to market and the costs are rising every day1. Only 50% of applications for drug marketing authorization (year 2000-12) were approved by USFDA on the first submission. Among applications that were delayed for approval, the median duration of the delay was 435 days, leading to substantial loss to the pharmaceutical companies in terms of sales2.
So what are the barriers to marketing approval of a drug? Reasons are multiple, it may be because the study has failed to meet its objectives, maybe the study drug is less efficacious compared to the standard of care or may be unsafe with risks outweighing the benefits. These reasons reflect the genuine failure of the drugs to achieve expected performance. Some reasons for delay or rejection by regulatory health authorities could be errors in study design and methodology, such as errors in dose selection, wrong choice of study endpoints.
Other denials/delays are due to operational inefficiencies resulting in inconsistencies in conduct of the study and results, and compliance and documentation issues. Documentation issues alone contributing to 3% of rejections3. Among these reasons, the operational, compliance and documentation issues are highly preventable (Figure 1).
Amidst, enormous pressure to get things right the first time and prevent any delays in regulatory decision making, the pharmaceutical companies always look for effective measures to achieve success. Among other measures required to increase the rate of acceptance, documentation issue is very much under control and can be easily fixed. Few pharmaceutical companies meet their regulatory writing requirements by setting up in-house medical writing departments, while a large proportion of companies outsource to medical writing agencies.
Strategic partner - throughout the drug development
A medical writing agency partners with pharmaceutical companies early in the drug development stage and acts as a strategic enabler in the success of the drug development process. The medical writing team is typically involved throughout the drug development process (Figure 2).
The role of a medical writer starts at an early stage contributing to the development of a Clinical development plan (CDP). Early involvement gives medical writing team the big picture that helps align them to the drug development strategy and avoids multiple iterations and reconciliation that happens otherwise. The medical writers are thus better positioned to understand the clinical team's requirement and process the downstream documents such as protocols, informed consent forms, and clinical study reports regulatory responses etc.
Medical writing services team is integral and plays a cross-functional cementing role within and across the clinical team. They liaise and capture relevant information from statisticians, clinical operations, clinical scientists within the clinical team and multiple stakeholders across different departments. They convert a huge amount of complex raw clinical data in a simplified, cohesive and accurate storyline. Medical writing services team not only create high quality, scientifically sound and regulatory compliant documents but also bring in operational efficiencies to pharmaceutical companies by optimally utilizing resources and time. They do so by well-defined processes, templates, checklists and close monitoring of timelines from kick-off to submission of the documents.
A good, medical writing services team partners with and mirrors the pharmaceutical company’s requirement. They ensure timely medical writing services through efficient project management, scientific research articulation, adherence to regulatory guidelines and cross functional communication, and robust documentation. A knowledgeable agency through its systematic approach does a significant value-add to the client. Partnering with a good medical writing agency can significantly bring down delays and rejections associated with marketing authorization applications.
- FDA, Dr. Gottlieb’s Speech to the Regulatory Affairs Professionals Society (RAPS) 2017 Regulatory Conference, Sept. 11, 2017, Washington, DC.
- Sacks LV, Shamsuddin HH, Yasinskaya YI, Bouri K, Lanthier ML, Sherman RE. Scientific and Regulatory Reasons for Delay and Denial of FDA Approval of Initial Applications for New Drugs, 2000-2012. JAMA. 2014;311(4):378–384.
- Ana Cerúlia Moraes do Carmo, Stefânia Schimaneski Piras, Nayrton Flávio Moura Rocha, and Tais Gratieri, “Main Reasons for Registration Application Refusal of Generic and Similar Pharmaceutical Drug Products by the Brazilian Health Regulatory Agency (ANVISA),” BioMed Research International, vol. 2017, Article ID 7894937, 10 pages, 2017. https://doi.org/10.1155/2017/7894937.