Biotech

Rethinking Clinical Trial Data in the Era of Decentralization

Sponsored By Seriant Jul 28, 2025 8:00am
Biotech


1. Introduction
 

Decentralized Clinical Trials (DCTs) are transforming how we collect clinical data, but this evolution brings unprecedented challenges in data quality, complexity, and integration.  DCT adoption has accelerated dramatically since 2011,1 increasing 1.7 times in the USA during 2020 alone,2 with the global market projected to surpass $21 billion USD by 2030 at a 14% compound annual growth rate (CAGR).3

Despite rapid growth, only 9.2% of DCTs are multiregional and over 80% single-country, indicating challenges in international implementation.2 With regulatory agencies4–7 underscoring risk-based oversight and robust data traceability, sponsors must build data architectures that keep pace with DCTs’ expanding scope and scale.


2. DCT Advantages:


DCTs offers several benefits over traditional, site-based trials.

  • Data is more readily available via the ability to plan more frequent remote visits per protocol (without increasing study participant burden) to support:
    • Earlier detection of safety signals or adverse events
    • Timely data capture supporting adaptive trial design
    • Better understanding of variability
  • Reduced recall and reporting bias through digital data collection that minimizes reliance on the study participant’s memory and the study personnel.
  • Increased population diversity8 by removing geographic and logistical barriers (e.g. travel requirements, limited scheduling flexibility, or mobility challenges related to the study participant’s health status).9


3. DCT Challenges
 

Despite DCTs’ advantages, each new data stream introduces operational and analytical complexity that must be managed from the start:

  1. Heterogenous data: Multiple sources, formats, collection methods, and diverse populations require standardization to support clean, consistent analysis10–12.
  2. Variable data quality and frequency: Participants’ data capture inconsistencies and improper device usage can compromise data quality. Device types, software versions, and adherence levels can complicate analysis plans.
  3. Missing and incomplete data: User- and device-related issues such as unreported malfunctions, forgetting to charge or maintain devices, and poor adherence to wearables can compromise data completeness.
  4. Data transfer and integration: Multiple vendors and systems require multiple Data Transfer Agreements (DTAs) that define how, when, and in what format data moves across platforms. The DTAs include setting up dataset integration for seamless, real-time data flow while maintaining data integrity and regulatory compliance.10–12
  5. System and source validation: All electronic systems and data sources must undergo rigorous validation and qualification for accuracy, reliability, and compliance with regulatory standards (e.g., FDA 21 CFR Part 11, European Medicines Agency (EMA) Annex 11),7(p11),13  including audit trails and user authentication protocols.
  6. Privacy and compliant storage: Global privacy regulations such as the General Data Protection Regulation (GDPR), Personal Information Protection and Electronic Documents Act (PIPEDA), and Health Insurance Portability and Accountability Act (HIPAA) mandate encryption in transit and at rest, storage on servers located in compliant jurisdictions, and clear cross-border data transfer policies.


If not accounted for from the outset, these aspects may impact the data quality and therefore the precision and robustness of the statistical analysis.
 

4. Strategies to Address DCTs’ Challenges
 

To mitigate risk and extract full value from DCTs, sponsors must ensure comprehensive planning:

Pre-Trial Preparation

  • Validate digital tools before the trial begins to limit variability and risk of missing or incorrect data.
  • Implement robust data security, encryption and data-transfer protocols.
  • Standardize collection methods across all sources and devices.


Operational Optimization

  • Train personnel and participants thoroughly to reduce missing or incorrect data collection.
  • Implement real-time and central monitoring for proactive issue resolution.
  • Develop a comprehensive data management plan outlining data flow, validation, and query resolution procedures.


Statistical Excellence

  • Develop a statistical analysis plan addressing DCT-specific challenges, especially missing data.


5. Implementation Considerations
 

When evaluating DCT adoption, sponsors should assess:

  1. Data strategy alignment: Ensure data collection methods provide adequate and reliable assessments of the study endpoints and are compliant with regulatory requirements.
  2. Technology readiness: Validate all digital tools and integration capabilities before deployment.
  3. Participant population: Consider digital literacy and access limitations in target population.
  4. Regulatory landscape: Understand regional requirements for data handling and privacy.
  5. Partner capabilities: Evaluate Contract Research Organization (CRO) experience with DCT complexities and integrated solutions.


Delivering decentralized clinical trials at scale demands more than digital tools—it requires foundational infrastructure built on three pillars: a validated, secure platform; deep operational expertise; and a proven track record in complex, global DCTs. Seriant brings all three with in-house engineering for pre-trial testing and tool validation alongside a purpose-built modular DCT platform and integrated data management & biostatistics. With experience in large, global DCTs—including pharmacogenomics— Seriant navigates DCT complexity with agility and precision, while keeping the participant experience front and center.
 

6. Conclusion
 

Modern DCTs require sophisticated data strategies and expert partnerships. Managing multiple data streams, ensuring quality across diverse sources, and maintaining regulatory compliance calls for specialized expertise across infrastructure, operations, and analytics.

Organizations that master DCT data challenges will gain significant advantages: improved participant access, enhanced data quality through continuous monitoring, and more efficient trial execution. With proper planning, validated tools, and experienced partners, sponsors can harness the full potential of decentralized trials while maintaining the data integrity essential for regulatory approval and scientific advancement.

As the clinical research landscape continues to evolve, those investing in robust DCT capabilities today will be best positioned to deliver tomorrow's breakthrough therapies to patients worldwide.

At Seriant, we partner with pharmaceutical, biotech, and medical device sponsors from Phase 1 to Phase 4 to unlock the full potential of decentralization in clinical trials— combining deep operational expertise, robust data strategies, and a participant-centric mindset to bridge the gap between scientific innovation and real-world impact.


 


 

References

1.  Pfizer Conducts First “Virtual” Clinical Trial Allowing Patients to Participate Regardless Of Geography. https://www.pfizer.com/news/press-release/press-release-detail/pfizer_conducts_first_virtual_clinical_trial_allowing_patients_to_participate_regardless_of_geography

2. Sato T, Mizumoto S, Ota M, Shikano M. Implementation status and consideration for the globalisation of decentralised clinical trials: a cross-sectional analysis of clinical trial databases. BMJ Open. Published online October 1, 2023. doi:10.1136/bmjopen-2023-074334

3. Research and Markets. Decentralized Clinical Trials (DCTs) Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, 2020-2030F. February 2025. https://www.researchandmarkets.com/reports/6051429/decentralized-clinical-trials-dcts-market

4. European Medicines Agency. Guideline on computerised systems and electronic data in clinical trials. Published online March 9, 2023. https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf

5. Good clinical practice for clinical trials. GOV.UK. March 13, 2025. https://www.gov.uk/guidance/good-clinical-practice-for-clinical-trials

6. Canada H. Management of Clinical Trials during the COVID-19 pandemic: Notice to Clinical Trial Sponsors. September 28, 2020. Accessed June 10, 2025. https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/announcements/management-clinical-trials-during-covid-19-pandemic.html

7. Office of the Commissioner. Part 11, Electronic Records; Electronic Signatures - Scope and Application. October 1, 2024. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application

8. Vayena E, Blasimme A, Sugarman J. Decentralised clinical trials: ethical opportunities and challenges. Lancet Digit Health. 2023;5(6):e390-e394. doi:10.1016/S2589-7500(23)00052-3

9. Jean-Louis G, Seixas AA. The value of decentralized clinical trials: Inclusion, accessibility, and innovation. Science. 2024;385(6711):eadq4994. doi:10.1126/science.adq4994

10. Data First: Building a Foundation for Digital and Decentralized Clinical Trials. Applied Clinical Trials. January 24, 2022. Accessed June 10, 2025. https://www.appliedclinicaltrialsonline.com/view/data-first-building-a-foundation-for-digital-and-decentralized-clinical-trials

11. Decentralized clinical trials. flaskdata. Accessed June 10, 2025. https://flaskdata.io/decentralized-clinical-trials/

12. Carr S. Decentralized Clinical Trials: the Future is Now. eClinical Solutions. August 16, 2022. https://www.eclinicalsol.com/news/decentralized-clinical-trials-the-future-is-now/

13.        The Rules Governing Medicinal Products in the European Union. In: GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, (Volume 2 - Regulations, Standards, and Guidelines). 0 ed. CRC Press; 2004:257-316. doi:10.3109/9780203026656-14

The editorial staff had no role in this post's creation.
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