USP 797 Sterile Compounding

ProSciento’s drug compounding procedures strictly adhere to USP 797 thus ensuring the safety of clinical study participants and supporting the successful execution of clinical trials. ProSciento’s Clinical Research Unit (CRU) in Southern California has a state-of-the-art USP 797/800 clean room (positive/negative pressure/ante room), 24/7 storage temperature monitoring and alarm system, and secure, controlled access drug rooms.

In-Patient Extended Stay Capabilities

ProSciento’s specialized early phase Clinical Research Unit (CRU) accommodates extended in-patient studies up to eight weeks, supported by a 24/7 medical team. This capacity supports protocols for complex early phase metabolic trials, including extended glucose clamp studies.

Specialized Methodologies

At ProSciento, we are committed to contributing to scientific discoveries and advancing clinical methods that support new therapeutic development worldwide. The breadth of our team’s expertise makes ProSciento a unique partner for the execution of sophisticated metabolic trials. Our proven expertise in specialized clinical methodologies include:

  • Automated glucose clamp
  • Stable isotope tracer methodologies
  • Imaging biomarkers
  • Circulating and functional biomarkers
  • Glucose, lipid, and mixed meal tolerance tests
  • Indirect calorimetry
  • Tissue biopsies

Medical Monitoring & Pharmacovigilance

ProSciento’s Medical Monitoring and Pharmacovigilance (PV) teams bring an unmatched level of scientific and therapeutic area expertise to ensure data integrity, safety, and mitigate risk 24/7 by working closely with clients, sites, and regulators.  Our physicians have a keen understanding of how to interpret pre-clinical, clinical, safety, and pharmacokinetics data to support effective dose escalation and safety reviews, and provide valuable expert input into phase 1 to 3 clinical study design, inclusion/exclusion criteria, PD/biomarker strategy, and regulatory requirements. For efficiencies and enhanced data transparency, we utilize a fully E2B (R3) compliant cloud-based PV system to enable fast evaluation of reportability, generation of regulatory reports, and signal detection. 

Data Management & Biostatistics

Good quality data are the backbone of a clinical trial as they determine if a study meets its primary and secondary endpoints. What further sets ProSciento apart is our team’s understanding of early-stage metabolic studies.  This informs how we build databases and the types of data we need to collect during both the early and later stages of a specific drug development program. Because our team members are certified, all database builds are in-house for speedier timelines and more flexibility due to fewer hand-offs throughout the study build process, saving weeks in database build time.  To enhance data quality, our team uses industry-best CDM, EDC, and CTMS systems, with a single access point for sites for data-driven metrics. Importantly, our data visualization tools give clients full transparency and custom reports of raw data and finished data in real-time. 

Investigational Product Management

ProSciento has a dedicated Pharmaceutical Services (PS) group that takes a science-driven approach to IP Management.  The group consists of pharmacists and researchers with longstanding expertise in early-stage metabolic trials—more than 200 to date. In addition to IP logistics, preparation, and storage, the PS group provides seamless integration with drug depot services for IP distribution for multi-site clinical trials and is highly skilled at conducting isotope studies, with single and dual tracers, for early phase clinical trials. Read more about ProSciento’s IP management services.

Clinical Monitoring

ProSciento’s Clinical Monitoring team consists of CRA professionals with focused expertise in metabolic clinical studies. This model is different in the industry, in that our CRAs are not working across several therapeutic areas at once, thus promoting efficiency and focus. Our CRAs are critical to our overall clinical trial management team and implement effective monitoring and risk mitigation strategies, ensuring patient safety, data integrity, and risk assessment. For each study, the lead CRA is the primary point of contact—a best practice that eliminates confusion that sites sometimes face in wondering whom to contact. Moreover, ProSciento’s proprietary CRA Score Card system tracks key performance indicators, including turnaround time for onsite monitoring reports, percentage of SDV backlog, and resolution of Issues in Action, helping to drive site performance and providing real-time actionable reporting.

Site Selection & Vendor Management

Selecting suitable sites with access to patients meeting protocol eligibility requirements is paramount to study enrollment success in clinical research. To bolster site selection, ProSciento has a strong global network of clinical trial sites and specialized vendors, curated over nearly two decades of expertise in metabolic clinical research. Additionally, ProSciento’s PRO PASS platform and database provide detailed diagnostic data to aid in optimizing I/E criteria and site selection based on patients that meet protocol eligibility. Overall, ProSciento’s depth and breadth of services help ensure streamlined site and vendor selection, improved enrollment, and accelerated study launch providing a dramatic and positive impact on the conduct of the entire study.

Patient Enrollment & Engagement

ProSciento provides its clients a significant advantage in patient access and enrollment via its PRO PASS™ diagnostic IRB-approved protocol deployed at sites across the nation and growing globally that provides detailed diagnostic data to aid in optimizing inclusion/exclusion (I/E) criteria and site selection based on patients that meet protocol eligibility.

ProSciento considers patient engagement and retention as a critical priority for all studies. Our Patient Recruitment and Retention team creates patient-centric, study-specific plans designed to optimize engagement throughout the patient’s journey in our clients’ studies. Our solutions leverage technology-based innovations, including automated text and email touchpoints, educational resources, and patient concierge services.

Regulatory Affairs

ProSciento’s therapeutic-specific scientific and regulatory expertise provides a distinct advantage in navigating the evolving global regulatory environment. Our Regulatory Affairs services typically begin with assessing IND readiness, analyzing regulatory options, and researching marketing opportunities afforded by each regulatory path, with a keen focus on evaluating where the product best fits into the standards of care for metabolic disease and what is needed from clinical and regulatory perspectives to achieve this goal. ProSciento’s Regulatory Affairs Team then provides project management for all document creation, submission, and representation of the client at meetings with FDA and EMA regulatory agencies.

Our regulatory track record speaks for itself with contributions to 17 approved metabolic drugs and devices and more than 100 submissions to the FDA’s Metabolism and Endocrinology Products (DMEP) and Gastroenterology and Inborn Errors Products (DGIEP) Divisions.