Clinical Feasibility & Site Selection Service
InquiryIn the high-stakes landscape of drug development, the transition from bench to bedside hinges on the precision of clinical trial placement. Protheragen provides an industry-leading clinical feasibility & site selection service designed to mitigate the risks of slow recruitment and sub-optimal data quality.
Strategic Clinical Feasibility & Site Selection Services
By integrating deep biological expertise with advanced predictive analytics, we transform the site selection process from a reactive exercise into a proactive strategy. Our approach ensures that every selected site possesses the necessary infrastructure, patient demographics, and investigator expertise to meet rigorous protocol requirements, ultimately accelerating time-to-market for transformative therapies.
Core Technologies
Protheragen utilizes a sophisticated, proprietary technology stack to ensure every site selected is mathematically and operationally primed for success. Our data-driven approach replaces traditional "gut-feeling" selection with verifiable metrics:
- Bio-Informatics Predictive Modeling
We utilize advanced algorithms to simulate enrollment scenarios based on historical performance data and current competitive landscapes.
- Electronic Health Record (EHR) Aggregation
Our platform accesses de-identified global patient data to verify the density of specific biomarkers and phenotypes required by the study protocol.
- Site Performance Analytics
A multidimensional database that tracks site-specific metrics, including regulatory turnaround times, screen-fail ratios, and data quality scores.
- Geospatial Patient Mapping
Advanced mapping tools to identify patient clusters and assess the impact of travel distance on retention rates.
Contact Our Team to Request a Tailored Feasibility Analysis for Your Upcoming Study
Solution Scope
Our clinical feasibility & site selection service is comprehensive, covering all phases of clinical development and diverse geographic regions.
- Patient Journey Mapping
Understanding the referral pathways to ensure sites can access the necessary patient volume.
- Investigator Interest Surveys
Gauging the enthusiasm and commitment of key opinion leaders (KOLs) before formal engagement.
- Regulatory & Ethics Feasibility
Assessing the timelines and requirements for local IRB/EC approvals to prevent startup bottlenecks.
- Site Facilities Audit
Ensuring specialized requirements, such as -80°C storage, centrifuges, or advanced imaging modalities, are available and validated.
Workflow
The Protheragen methodology follows a structured, five-stage process to ensure every clinical site is primed for high-quality execution.
Fields of Application
Our services are tailored for complex therapeutic areas where site expertise and patient access are critical.
- Oncology & Immuno-oncology: Identifying sites with access to specific genomic subpopulations.
- Rare & Orphan Diseases: Locating concentrated patient clusters in geographically dispersed regions.
- Cell & Gene Therapy: Evaluating sites for specialized handling, processing, and long-term follow-up capabilities.
- Neurology & CNS: Assessing sites with specialized diagnostic equipment and experienced raters.
- Cardiovascular & Metabolic Disorders: Identifying high-volume centers with robust primary care referral networks.
Advantages
Partnering with Protheragen provides sponsors with a significant competitive edge in the race to market.
Data-Driven Accuracy
Our feasibility projections maintain an accuracy rate within 10% of actual enrollment performance. In obesity research, this precision eliminates the need for costly rescue studies and ensures that metabolic data sets are complete and statistically significant.
Rapid Startup Timelines
By leveraging a network of sites with streamlined administrative processes, we accelerate the "first patient in" (FPI) milestone. Our specialized metabolic site database reduces start-up delays, getting your weight-loss therapy into the clinic weeks ahead of schedule.
Biological Expertise
Unlike generic CROs, our team consists of PhD-level biologists who understand the nuances of GLP-1 agonists and other molecular targets. This expertise ensures that recruitment criteria align perfectly with the therapeutic mechanism of your compound.
Risk Mitigation
We identify potential pitfalls in study design early, allowing for protocol amendments before implementation. By simulating metabolic patient journeys, we proactively address common drop-out risks, protecting your investment and ensuring a smoother path to regulatory approval.
Consult with a Protheragen Specialist to Optimize Your Site Selection Strategy
Customer Review
Strategic Insight & Rare Disease Expertise
"Working with Protheragen completely changed our approach to Phase II planning. Previously, we struggled with optimistic site reporting that didn't materialize into actual patients. Protheragen's data-driven vetting identified three high-performing sites we hadn't even considered. Their biological understanding of our rare disease target was the differentiator."
Dr. C.O., Mid-sized Biotech
Data-Driven Roadmaps for Global Portfolios
"The feasibility report provided by Protheragen was the most detailed we have seen in 15 years. It didn't just give us numbers; it gave us a strategic roadmap. We are currently in the process of expanding our partnership with Protheragen to cover our entire respiratory portfolio."
Dr. D.C., Global Pharmaceutical Firm
Frequently Asked Questions
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How does Protheragen ensure the accuracy of enrollment projections?
We combine historical site data with real-world EHR evidence to create a multi-layered projection model, rather than relying solely on investigator-reported estimates.
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Can you assist with global site selection?
Yes, Protheragen has an extensive network across North America, Europe, and emerging markets in APAC and LATAM, ensuring diverse patient representation.
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What is the typical timeline for a feasibility assessment?
A comprehensive global feasibility study typically takes 4 to 6 weeks, depending on the complexity of the protocol and the number of regions involved.
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How do you handle competition from other trials at the same site?
Our landscape analysis identifies "competing" trials. We prioritize sites where your study will be a primary focus for the investigator and staff.
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Do you provide services for Phase I/first-in-human studies?
Absolutely. We specialize in identifying Phase I units with the necessary safety infrastructure and experience in complex dose-escalation protocols.
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What happens if a selected site underperforms?
Our service includes ongoing monitoring of site performance. If a site fails to meet milestones, we provide remediation strategies or identify backup sites immediately.
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Is your site selection process compliant with GCP?
Yes, all qualification activities and documentation are strictly aligned with ICH-GCP guidelines and local regulatory requirements.
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How do you assess the "rescue" potential of a failing study?
We conduct a rapid "gap analysis" to identify why the current sites are failing and deploy a targeted selection of "high-performer" sites to get the trial back on track.
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Can we use Protheragen for site selection only, without full CRO services?
Yes, our feasibility and site selection services are available as a standalone functional service provider (FSP) model.
Contact Us
Protheragen is committed to transforming clinical trial outcomes through scientific excellence and data-driven precision. Our clinical feasibility & site selection service ensures your study starts on the strongest possible foundation, minimizing delays and maximizing data quality.
Contact Protheragen for More Information and to Discuss Your Project
All of our services and products are intended for preclinical research use only and cannot be used to diagnose, treat or manage patients.