We give researchers the data they need through our strategically designed Phase I healthy volunteer studies.
Phase I healthy volunteer studies play a vital role in clinical research by providing researchers with the knowledge they need to make educated decisions. We provide our partners with a full suite of Phase I-IIa clinical research services at our state-of-the-art clinical pharmacology centers located throughout Central and Eastern Europe and the US. These services include study design flexibility, specialized equipment to monitor safety and pharmacodynamics, an in-house pharmacy, expedited regulatory approval, rapid data processing, and a large pool of more than 40,000 healthy volunteers. We also manage global, third-party Phase I clinical sites through our external site management model.
Meeting aggressive patient recruitment deadlines and targets.
Active volunteers and patients40,000+
Subjects enrolled per year in the Netherlands1,600+
Historic recruitment rate>95%
Historic on-time first-subject-in>95%
Maintaining a pool of volunteers is critical to getting a project underway as quickly as possible. We’ve built relationships with a large base of ready and willing subjects who are the foundation of our subject recruitment efforts. This active pool of more than 40,000 volunteers and patients includes both healthy volunteers and various specific patient populations from the Netherlands, Belgium, and the US. We continuously augment this comprehensive subject database through active recruitment strategies.
We also deliver higher recruitment rates and better data quality in pharmacokinetic (PK) studies for more difficult to recruit patient populations, including elderly men and women, post-menopausal females, and overweight/obese subjects. We utilize in-house call centers, community outreach teams, transportation services, physician referral networks, and our formalized relationships with external hospitals to assist with recruitment. Our extensive patient database includes over 100,000 disease-state and healthy volunteers.
Supporting the dispensing and on-site manufacturing of investigational products.
Our GMP-compliant pharmacy is central to our clinical facility and equipped to support all drug storage and preparation requirements, including a fully monitored and validated clean room environment and radio-isotope area. We offer tailor-made preparations, per study batches, adaptable doses during FiM design, small scale manufacturing, and pharmaceutical QC analysis to ensure an earlier start to your clinical program, fewer contracts, and lower costs overall.Learn more about our on-site manufacturing capabilities for early clinical drug development.
Measuring success across a wide range of healthy volunteer studies.
By leveraging our large base of volunteers with our global infrastructure and therapeutic expertise, we can deliver real results. Our healthy volunteer expertise includes:
Our research sites in Salt Lake City are dedicated to successfully conducting dependency studies, and our extensive database has over 3,000 addiction subjects. We’ve conducted over 70 studies in addiction and consulted on many addiction trials, particularly in the areas of study design, treatment arms, comparator agent, neurocognitive and other assessments, along with the provision of protocol writing and full statistical analysis. We are licensed to handle controlled substances, Schedule II, III, IV, and we have experience administering IV controlled substances.
Human Abuse Potential (HAP)
We’ve conducted more HAP assessments across multiple classes of compounds than any non-academic clinical research site in the US, including studies that led to abuse-deterrent labeling and/or marketing materials for more than half of the ten opioid pain medications currently labeled by the FDA as having abuse-deterrent properties. Our ongoing relationship with the FDA and the Controlled Substance Staff (CSS) ensures that our programs align with current regulatory guidelines.
ADME & Microdosing
We run ADME studies in a separate, dedicated, and licensed clinical research isotope unit in our Netherlands clinic. Trained medical and nursing staff supervises clinical conduct, while dosing of a radiolabeled drug product is in the hands of dedicated medical investigators who are specifically licensed as radiation safety officers according to Dutch regulations.
As the first company to perform microdosing studies, we laid the groundwork for world-wide acceptance by running the well-known CREAM and EUMAPP validation trials. We undertake more Phase 0 microdosing studies at our Netherlands facility than any other unit in the world.
We offer comprehensive, cross-functional support for biosimilar development programs, including consultation, regulatory, early development services, bioanalytical, and study conduct. Our Early Development Services (EDS) group has conducted both large Phase I healthy volunteer biosimilar studies involving over 400 subjects, as well as trials with new monoclonals where first into-man was in healthy volunteers.
We’ve established proven processes and guidance documents, as well as clinical team training on how to perform ECG extractions stringently and effectively. Working alongside several major core ECG providers, our team has successfully conducted 16 TQT studies.
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