Digital Transformation in Clinical Trials

A rapid digital transformation is impacting all areas of Clinical Development. Clinical organizations are implementing more agile trial planning and execution processes. Responsibilities and decision ownership are being distributed to support faster decision making. The advent of COVID-19 has accelerated this change, as both sites and patients require solutions with less physical contact and more flexibility.

Pharma and biotech companies are increasingly implementing new solutions to support a more patient-centric trial execution approach to accommodate these new requirements and are at the same time struggling with keeping down the cost and new practical study burdens for both sites and patients.


The trend towards a higher level of digitalization has been ongoing for the last 15 years. Initially, the focus was on digitalizing the internal sponsor processes with systems like EDC, where data capture was moved from paper to being directly entered by the sites into EDC, more advanced clinical management systems for consolidating and cleaning data, and even bigger statistical solutions for analysis. In parallel, many pharma companies have implemented Clinical Trial Management System (CTMS) applications to support the clinical operations side.

Despite all these initiatives, except for EDC, the promised cost and efficiency savings have not materialized.

One of the most important reasons is that the processes have not been allowed to follow suit with the development of technology. A digital transformation cannot be successful without radically changing the related processes, and many companies have, at least partially, held on to their previous processes, thereby missing out on the full benefits of digitalization.

That is now changing, and we see several trends that are supporting this change in mindset.

Improved IT support of Clinical Development  
IT is supporting the business with what they need to work smarter. Instead of working in separate silos, IT and Clinical Development are working together to optimize the use of budgets available to them, prioritizing how to improve business processes with funds available best.

Using new digital solutions entirely  
When selecting a solution, ensure it supports all clinical processes, not just a subset. Many vendors claim they fully support all relevant processes in their application, but very often entire process areas are missing, forcing the business to keep using spreadsheets and separate documents. To avoid this, there are two different approaches, both of which begin with mapping out your processes and defining which processes are essential. Based on this you can choose to either select only solutions that cover all your processes (essential and non-essential) or select a solution that covers your fundamental processes and include the remaining processes in your contract when they are available.

More focus on the patient
Patients want to be involved in their health. Instead of only targeting the patient when needed for a trial, and selling the product when approved, sponsors now look at the patient life cycle. The first step can be made by creating patient communities, providing insights to the patient, guiding them, and involving them in activities related to their disease. This is followed by a request, through investigators, to participate in trials. After participation, the cycle is continued with community activities and helping the patient to a better life. The intent naturally is to be the preferred supplier of medication, if it fits the patient’s disease profile.

The immediate implication of COVID-19 has accelerated the digital transformation and the patient-centricity focus within pharma. Patients prefer to reduce the visits at the site or avoid them altogether. Sites are under a high workload, dealing with both trial participants and patients, and would like to reduce both their own and patient onsite exposure. To support this shift sponsors are changing procedures and procuring new services to shift activities typically handled at the site to be able to be managed by the patient at home.

Advancement in Virtual Trial support solutions
The accelerated need for solutions supporting virtual trials, like eCOA, eConsent, device support, and associated services such as home health nurse-, concierge services, and virtual study coordinators has pushed the development of all these study capabilities. Vendors have developed these capabilities and integrated them into platforms allowing sponsors to select from a menu of abilities depending on the needs of the trial.

Digital Transformation

Moving forward, IT and Clinical Development will not only work together on digitizing the internal processes but also on enabling the trials to reach both investigators and patients using digital tools easily. By creating a complete picture of all the core capabilities needed both internally and for the studies at the site and at home with the patient, it is possible to map the tools and solutions to the processes and decide on an implementation priority. In regards to resources, the first focus should be on the immediate needs of the studies to adapt to the new reality by implementing virtual trial support, and then on achieving a real digital transformation internally.

Vendors often claim they can transform the business and help bring a medical or device product faster to market; however, this is never the case. Only more efficient processes using new digital tools can truly optimize time to market. When selecting the solutions, e.g. CTMS, EDC, eTMF, RIMS, and others, it is vital to ensure the business gets the best solution meaning all processes become digital. If some processes still require manual support or tracking sheets after a new solution has been implemented, it was the wrong solution.

Integrations between systems are imperative, e.g. CTMS must exchange monitoring reports with your eTMF. If not, the solution does not support your monitoring report workflow. Therefore, it is highly recommended to buy a solution that supports integration as part of the standard package. All serious vendors support integration with most other relevant vendors as part of their standard solution. Vendors who lock your clinical operations department into only being able to select further modules of their solution, should not be considered an option.

Open systems provide freedom to upgrade key components as they need to change and support the changes in the organization and clinical, operational model as the pharmaceutical or biotech company evolves. As trial execution moves from outsourced to insourced, the organization changes and partnerships are increasing, the IT system scalability and agility becomes key. Your IT solutions must support changes like these, and that is only possible if all processes are fully digitalized and integrated.

The impact on Clinical Development when needing to digitalize all processes can be substantial. A strategy for the digital transformation must be developed, to ensure that the essential capabilities can be implemented first without impacting the business unnecessarily and disturbing daily operations. To plan this transformation, key staff in Clinical Development and IT together with management must agree on the digital vision. Once this is done, the definition of capabilities, development of user stories and requirements, vendor selection, and implementation planning can take place, followed by a phased implementation.

About the author

John Aggerholm
Project Director & Partner

John is the founder of HERAX. He has worked for 7 years at a subsidiary of Novo Nordisk A/S, as VP for eClinical Process Consulting, specializing in clinical processes in R&D and execution of eClinical programs. Before Novo, he worked for 5 years as CIO in IBM Denmark, and prior to that in IT and Clinical Operations at Henri Beaufour Institute Inc. in the US.