Anyone who works in clinical research understands that it is a dynamic discipline that is full of change and challenges. Traditional business challenges are merging with new market pressures and motivating change across the industry. As a result, they are transforming the way we work and how we interact with clinical data.
Traditional Business Challenge
The three most impactful and continuing challenges of clinical research are budgets/resources, timelines and compliance. A constrained budget impacts timelines. Tightened timelines impact budgets and compliance efforts. Noncompliance can lead to safety issues, bad publicity and investor concerns that can impact commercial viability. These highly connected challenges have always been priorities for development teams. They have also motivated innovation and the application of new technologies to improve the clinical research process.
Emerging Business Challenges
New and evolving business challenges are expanding on traditional business challenges. Clinical trials are increasing in complexity. Adaptive trial designs, increased number of endpoints and a new focus on the patient voice are adding complexity to clinical trials. Simultaneously, shifting outsourcing trends and globally dispersed teams are adding complexity to the underlying operating models.
At the same time, data is coming from entirely new sources as electronic health records, wearables and IoT (internet of things) are employed. These new sources help physicians diagnose and manage disease states more effectively, but they also require new collection, storage and analysis and reporting processes.
There is also an emerging need for greater flexibility throughout the clinical trial process. A new level of responsiveness is required as new, previously unavailable insights drive changes to the ways we interpret and react to data.
Finally, these challenges are also driving a greater demand for automation. Data capture, management, analysis and reporting activities are changing as new technologies leverage artificial intelligence and business process insights to deliver higher quality data to expanding audiences.
Impact on Clinical Research
The combination of traditional and emerging challenges is motivating process and technology innovations across clinical research. Clinical trial sponsors and contract research organizations (CROs) are exploring different technology strategies to gain efficiency, maintain compliance and save money as they design and conduct more complex trials, and try to glean greater insights from unprecedented amounts of data. These strategies demand flexibility and rely on automation of critical data management tasks.
Taking a pragmatic approach to technology – balancing functionality with practicality, features with costs, and overall investment with direct value – can be a successful strategy in this tumultuous environment. In our next blog, we’ll define the term, Pragmatic Modernization, and describe how companies can use it to address emerging demands while still effectively managing the traditional pressures of budget, efficiency and compliance.
You can also read more about Pragmatic Modernization in our white paper.