Pharm-Olam International, Ltd.
Allucent is a dedicated partner in drug development, focusing on supporting small and mid-sized biotech companies through comprehensive clinical and regulatory services. Their mission is to help bring new therapies to light by providing expert knowledge, a global network, and innovative data-driven solutions, guiding science through the complexities of drug development to deliver therapies for patients worldwide.
Industries
Nr. of Employees
large (251-1000)
Pharm-Olam International, Ltd.
2000 Centregreen Way, Suite 300, Cary, North Carolina 27513
Services
End‑to‑end clinical development services covering protocol design, study execution across phases, study start‑up, site feasibility and global operations.
Design and implementation of clinical pharmacology programs including FIH studies, PK/PD analyses, PopPK, exposure‑response modeling and simulation to inform dose and study design.
Regulatory intelligence and strategy development, preparation of global regulatory submissions, orphan designation support and pediatric investigation planning.
Post‑marketing safety programs, pharmacovigilance planning and execution, including design and implementation of PASS and long‑term safety monitoring.
Specialized clinical research services for government and public health sponsors, including contract negotiation, compliance support and reporting.
Operational delivery including project management, centralized monitoring, eTMF management, clinical data management, biometrics, and biostatistics/programming.
End‑to‑end clinical development services covering protocol design, study execution across phases, study start‑up, site feasibility and global operations.
Design and implementation of clinical pharmacology programs including FIH studies, PK/PD analyses, PopPK, exposure‑response modeling and simulation to inform dose and study design.
Regulatory intelligence and strategy development, preparation of global regulatory submissions, orphan designation support and pediatric investigation planning.
Post‑marketing safety programs, pharmacovigilance planning and execution, including design and implementation of PASS and long‑term safety monitoring.
Specialized clinical research services for government and public health sponsors, including contract negotiation, compliance support and reporting.
Operational delivery including project management, centralized monitoring, eTMF management, clinical data management, biometrics, and biostatistics/programming.
Expertise Areas
- Clinical trial management
- Clinical pharmacology and translational science
- Regulatory compliance and global submissions
- Biostatistics and data analytics
Key Technologies
- PK/PD modeling and simulation
- Population pharmacokinetic (PopPK) modeling
- Clinical trial simulation
- Decentralized clinical trial (DCT) platforms and methods