Pharmaceutical companies conduct clinical trials to test the safety and efficacy of new drugs. These trials are complex and costly, and often involve thousands of patients across multiple sites. Traditional clinical trial design is a linear process that can take years to complete, leading to delays and high costs.
PureSoftware is a technology solutions company that specializes in agile methodologies. They have developed an agile clinical trial design approach that helps pharmaceutical companies streamline their clinical trial process, reduce costs, and improve patient safety.
Our client, a leading pharmaceutical company, faced the challenge of complying with regulatory requirements while delivering clinical trials with high quality and reducing costs. With the increasing demand for treating intractable illnesses, the client needed to ensure patient safety while accommodating protocol amendments and delivering faster results for quicker data analysis. The client also wanted the flexibility to modify trial designs and minimize changes in the future.
PureSoftware analyzed the client’s requirements and found that the traditional Waterfall methodology was not suitable for the client’s needs. The client required a more flexible and faster approach that could accommodate changes and fixes to trial designs quickly. PureSoftware suggested using the Agile methodology, specifically the Sprint Process, to replace the Waterfall method.
PureSoftware implemented the Sprint Process for a pilot study and then for all clinical trials of various sizes and complexities. The team discussed the number of sprints with the client and reviewed the workable requirements, such as draft protocols. The study’s design and build were done in parallel, with a difference of a few days to ensure that the content was ready for the client’s review.
The delivery of each sprint included a demo of the design to the client, which included mappings and calculations. The team accommodated changes and fixes to the design at the end of each sprint post finalization of requirements. PureSoftware offered flexibility to modify trial designs and minimize future changes.
Agile methodology delivered successful outcomes, with 150+ start-up and 640+ post-production projects. The client achieved high-quality clinical trials with a defect rate of <2%, and reduced project timelines.
Project A (haematology) was completed in 8-10 weeks, while Project B (endocrinology/cardiology) took 11-12 weeks due to its larger size. Agile methodology accommodated regulatory recommendations, resulting in a change in trial designs. Additionally, online reviews allowed for modifications to the designs, minimizing changes in the future.