Functions from clinical to safety can gain from a focus on data and process excellence this year.
With drug development becoming increasingly complex, biopharmas are striving for research and development (R&D) efficiency, a better experience for patients, and tighter collaboration with sites and CROs. The rise of AI has underscored the importance of a robust data foundation with seamless workflows to be more effective. Here are five trends that will shape biopharma and optimize R&D through streamlined processes and unified data in 2025.
Process excellence will accelerate content and data flow across R&D
Today, a simple and vital task, like turning adverse events in EDC into safety cases, can run the gamut from being an automated workflow at one company to requiring hours of manual effort across disparate systems at another. These inconsistencies slow drug development, and patients ultimately bear that burden. In 2025, biopharmas will focus on process excellence to improve the flow of content and data across R&D.
Now that sponsors are seeing the limits of disconnected, best-of-breed solutions, the industry is ready to standardize and simplify. This will be driven by investments in process standards. Some companies may focus on workflow automation to improve the flow of content and data across clinical, regulatory, safety, and quality. Others may rethink the way their organizations are structured to create dedicated process excellence teams.
Underrepresented patients will get more choice
Patient enrollment and retention continue to challenge sites and sponsors, with trial complexity and patient fatigue contributing to high dropout rates. In 2025, sponsors that give patients more options for onboarding and trial visits will improve their experience and expand the participant pool to previously underserved populations.
New FDA draft guidance on Diversity Action Plans urges sponsors to enroll more diverse patients and show the statistical breakdown of these groups in their trials. This will affect how data is processed and analyzed for submissions, to ensure enough clean data is available to meet statistical endpoints for each demographic subgroup.
More patient options mean more data inputs and complexity. From monitoring subgroup enrollment and retention to data management and statistical analysis, unified data at the center will enable patient participation at the edges.
Sponsors will step up to solve site capacity issues
Clinical research sites are the backbone of drug development. But, as the number of global clinical trials increases, the clinical site workforce is decreasing with high staff turnover rates. Complex protocols with multiple amendments and too many sponsor technologies per study are pulling site staff away from patients, limiting their capacity to take on more trials.
As sponsors rethink their site engagement strategies in 2025, they will prioritize consistent site technology and standardization across sponsors for all trials. With 55% of sites reporting that their top challenge is supporting a variety of technologies, sponsors will drive standardization to avoid major slowdowns in their pipelines.
The less time sites spend doing administrative work in systems, the more time they have to execute trials and help patients. This shift will help sites rebuild their capacity and ensure that drug development doesn’t stall.
CRO data visibility will improve study success
In 2025, sponsors will prioritize contract research organizations (CROs) offering full and continuous data transparency so they can start deriving insights immediately. As they pursue end-to-end data ownership, there will be a notable shift in dynamics when outsourcing clinical trials.
Sponsors and their chosen partners will start sharing data more fluidly across their systems: for example, to inform protocol design, onboard additional sites, identify potential rare disease participants, and move study endpoints. With access to live data as the new baseline, clinical development stakeholders will be more responsive to study changes. This can improve the probability of the trial succeeding and potentially reduce the time to get new medicines to patients.
Emerging biotechs, sometimes fully outsourced, will benefit from improved oversight and be able to make decisions more nimbly. Data transparency will create greater trust, allowing sponsors of all sizes to collaborate efficiently with their CRO partners.
Comprehensive and reliable patient safety data will fuel advanced automation
Pharmacovigilance professionals continue to grapple with an age-old question: how to handle growing data volumes with fewer resources while maintaining high quality. AI holds promise to do more with less, but inconsistent and disconnected data creates risk.
To effectively support AI, safety teams will strengthen their data foundations with standardized, end-to-end safety processes. Cross-functional workflows will eliminate manual data transfers and provide clear data traceability back to the source. By simplifying and standardizing their systems landscape, companies will lay the groundwork for accelerating automation and AI innovation.
This end-to-end data flow also opens the door for improved collaboration across organizations. For example, processes like timely reporting of serious adverse events (SAEs) from clinical EDC systems to safety can be done automatically with more complete data.
Making strides in R&D for all stakeholders
Data and process mastery will improve how stakeholders collaborate to advance the industry. Patients can gain more options to participate in clinical trials, sites can focus on patient care with improved technology and process standardization, CROs can collaborate more effectively with data transparency, and sponsors can automate their safety workflows.
With advanced processes, clean and reliable data, and modern applications, biopharmas can create greater efficiency, prioritize patient and site experiences, and deliver new therapies to patients faster.

Jim Reilly
Jim Reilly has over 20 years of experience in life sciences industry software, strategy, and consulting. Today, Jim leads the strategy, execution, and growth of Veeva Development Cloud and is the current chair of The Association of Clinical Research Organizations (ACRO).