
Introduction
With over 50%[1] of drugs in development reflecting rare/orphan and oncology indications alone, the complexity amongst patient cohorts is real with the patient identification-recruitment-enrolment bottleneck becoming the single greatest critical factor (as if it wasn’t already) in the success of any clinical program. It is little wonder we are witnessing the proliferation of patient and site access organizations to augment a clinical trial sponsor’s reach to increasingly nuanced patient populations. If investment is any indicator, this trend is indeed gaining momentum – there have been over fifteen transactions in the patient access organization space in the last 24months[2]. Private equity has particularly taken an interest in the growing site management organization (SMO) market to either build out or aggregate/scale site networks and site management organizations.
However, for this new category of patient access organizations, the ability to execute is everything. And with sound execution will come increasing requests for additional scale and operational capabilities. Today this is evident by the increasing requests for scientific insights from resident site management organization (SMO) therapeutic expertise. This potentially provides increased optionality and a relief to sponsors who may want to side-step traditional CROs entirely in lieu of a more direct path to patient; especially for studies that may not require a global Phase 3 study.
This paper provides a path forward for SMOs looking to do more for their partners by leaning into vital services to accelerate the delivery of high-quality data back to a pharmaceutical, biotechnology partner, or sponsoring medical technology,
From Networks to Organizations: The Rise of Site Research Organizations in Clinical Trials
The growth of more centrally administered site management organizations (SMO) from loosely connected site networks is just the beginning. A broader macro-shift is afoot – we are experiencing a fundamental disruption across the traditional clinical research industry with new site and physician-driven organizations built to offer innovators a more direct path to patients. And when combined with a more comprehensive suite of services, a path for sponsors to circumvent CROs entirely for select study types (e.g. those with accelerated filing, where a large global Phase 3 may not be needed) can be imagined – a new ‘site research organization’ model or SRO.
We can expect those site management organizations looking to evolve into an SRO will move towards partnering or investing in one or many of the following:
- Technology Integration: Where SROs leverage advanced technologies like EDC systems, eSource, telehealth platforms, and data analytics tools to optimize clinical data collection, management, and analysis.
- Biometric Expertise: SROs incorporate (or partner with) critical biometrics capabilities (e.g. biostatisticians, programmers, clinical data managers, etc.) for high data quality
- Expanded Service Portfolio: Join in the strategy discussion with SRO physicians (and patients) weighing in on study design support, protocol development
- Regulatory Affairs: Medical writing, publishing and submissions, regulatory strategy, pharmacovigilance and safety
- Patient-Engagement Platforms: Stronger patient engagement and retention through personalized communication, decentralized trial models, and convenient access to trial-related information.
SROs are poised to play an increasingly important role in the future of clinical research. As they continue to evolve and expand their capabilities, they will likely drive further innovation and efficiency in clinical trials.
To this end, Bioforum, the leading technology-enabled biometrics company, has specifically positioned itself for those SMOs looking to do more for their partners.
Bioforum and SMOs: A few observations
Over the course of the past 24 months, Bioforum has partnered with several SMO to support a variety of clinical programs. By leveraging Bioforum’s end-to-end ingest-standardize-visualize model, SMO partners have been able to collect, manage, and analyze complex physiological and behavioral data from multiple sources, ensuring accurate, reliable and complete data capture[3] from both structured and unstructured sources.
Critically, the combination of Bioforum’s technical expertise with an SMO’s operational experience creates a highly efficient delivery model proven to reduce administrative burden and accelerate trial timelines; synergies that further optimize transparency, security and privacy throughout every stage of the trial, from data collection and management to analysis and reporting. Bioforum’s partnerships with SMO and site network partners have allowed these SRO-ambitious companies to provide outsized benefit to their respective sponsors through:
- Enhanced data quality and integrity – Minimized data errors given “always-on” data quality reviews, integrated data validation and real time data visualizations
- Improved efficiency and cost savings – Zero SAS or programming even for the most complex conversions (partners experiencing 25%-40% reduced cost with higher quality)
- Regulatory compliance and faster approvals – A trusted audit trail providing forward and backward data traceability for every data point; facilitating faster FDA review cycles
- Strategic expertise and support – Optimized study outcomes with valuable insights into trial design, statistical methodologies, and endpoint strategies
- Patient diversity – Access to advanced analytics and real-world data to identify underrepresented patient populations, characterize their care networks, integrate data-driven diversity plans into programs and proactively monitor participation
Bottomline
The evolution of Site Management Organizations into Site Research Organizations (SRO) represents a pivotal shift in the clinical research landscape. Driven by the increasing complexity of patient cohorts, particularly in rare diseases and oncology, and the need for more efficient, patient-centric trial approaches, SROs are poised to provide sponsors increasing optionality to advance clinical programs with improved quality, reduced timelines and reduced administrative burden. A key enabler of this ideal is partnering with specialized biostatistics and clinical data management leaders, like Bioforum, that integrate cutting-edge technologies with a site network or SMO’s direct and efficient path to patient.
About the Author
Bryan Katz is a senior Pharma Life Science industry advisor and CEO of PharmaStreet Research. With extensive experience in deal strategy, innovation, and enabling technologies, Bryan has held leadership roles at ProPharma, Syneos Health, KCR, IQVIA, PwC, and Abbott Laboratories. His expertise supports Bioforum’s growth strategy, partnerships, and innovation initiatives.
Resources
[1] Yale University. Biotechnology & Pharmaceutical Industry: Pipeline, Trials, and Regulatory Information. https://guides.library.yale.edu/biotech-pharma/pipe-trials-regs
[2] Crosstree Capital. Clinical Trial Patient Organizations: An Emerging Ecosystem. 2024
[3] 100% guaranteed from Bioforum