Compliance, Quality & Cost: Outsourcing Clinical Trial Support
Compliance, Quality & Cost: Why Outsourcing Clinical Trial Support Makes Sense for Start-Up and Mid-Sized Drug Manufacturers
Clinical development of a drug or device from discovery through post-marketing approval requires a vast amount of time and resources. During the clinical trial phase, requirements and regulations imposed by governing regulatory bodies increases the amount of time and effort needed to reach approval. It is now estimated that the average length of time from the start of clinical testing to marketing is 7.5 years and the cost to bring a new drug to market is roughly $161 million- $2 billion! 1 This cost and effort can add up quickly and easily overwhelm a start-up — or even a mid-sized manufacturer.
Start-ups are wise to consider outsourcing their medical and safety activities during clinical trials to partners capable of providing a complete solution, from medical monitoring and information support to adverse event intake, pharmacovigilance case processing, safety database hosting and regulatory reporting. Outsourcing allows the internal medical, safety, and regulatory team to focus on core competencies. For mid-sized companies too, having a trusted outsourcing partner is crucial in ensuring regulatory compliance, quality and controlling costs.
Pharmacovigilance during the clinical trial process can mean the difference between a drug/device becoming approved or not. With complex regulatory standards and protocols, both domestically and globally, it’s very difficult to stay current on local regulations. Partnering with a knowledgeable and experienced medical and product safety team enables the manufacturer to remain compliant to regulatory guidelines and timelines while optimizing efficiencies.
Like compliance, maintaining consistency and quality during a clinical trial is crucial to its success. Properly collecting study data, answering queries from investigators, and identifying and reporting adverse events and product quality complaints, is critical. This requires highly skilled and experienced professionals to manage and report serious events with complex (i.e. expensive) electronic data capture systems and safety databases. It is costly to have these professionals and technology ever ready for events to occur, especially small or mid-sized companies, with fewer products. Having an outside company who specializes in these areas and can easily scale based on volume is a proven, effective approach. This brings us to the last point, which is, of course, cost.
The rising costs involved in conducting clinical trials are no secret. Along with the aforementioned $161 million – $2 billion to bring a new drug to market, there is also the notion that the average cost of developing a drug has risen at a rate 7.4% higher than inflation over the past two decades, mostly due to rising clinical trial costs.1 As is the case in many industries, outsourcing helps mitigate these financial risks.
Outsourcing allows trial sponsors the flexibility to handle volume fluctuations during advanced stages of clinical development with ease. A company specializing in clinical trial medical information and product safety can effectively staff up with highly qualified personnel, saving time and money in recruitment and training costs.
A compliant database for hosting safety data obtained during a clinical trial is necessary and can be very costly. Outsourcing with a partner who has knowledge validating, implementing and hosting this database can also save time and money, eliminating the high cost of ownership, maintenance and burden on their internal IT resources.
Clinical drug development can be a long, complex and expensive journey, especially for a start-up or mid-sized company. Outsourcing medical activities can be a significant advantage, allowing the sponsor to focus on their core business goals, while the experienced partner focuses on keeping their clinical trial compliant, ensuring the highest quality and decreasing costs.
Tags: adverse events, clinical trials, drug safety, FDA, medical information