Pharm-Olam LLC dba Allucent
Allucent is a global contract research organization dedicated to supporting small and mid-sized biotech companies in drug development. With over 30 years of experience, they provide comprehensive solutions across all phases of drug development, including clinical trials, pharmacology, regulatory strategy, and post-marketing surveillance. Their mission is to help bring new therapies to light by solving the unique challenges faced by biotech innovators, leveraging therapeutic expertise, operational excellence, and a global network across more than 75 countries.
Industries
Nr. of Employees
large (251-1000)
Pharm-Olam LLC dba Allucent
Cary, North Carolina, United States, North America
Products
Regulatory Strategy and Product Development
Support for navigating regulatory landscapes, including regulatory intelligence, global strategy, and submissions for IND, NDA, orphan drug designation, and pediatric investigation plans.
Clinical Pharmacology
Design and conduct studies to assess pharmacokinetics and pharmacodynamics, including first-in-human studies, population PK, simulation and modeling, and clinical trial simulation.
Preclinical Capabilities
Conduct in vitro and in vivo studies to support early drug development.
Clinical Trial Design
Design clinical trials including first-in-human, dose-escalation, and proof-of-concept studies.
Data Management and Analysis
Provide accurate and timely data management and analysis to support decision-making and regulatory submissions.
Biostatistical Programming
Offer biostatistical programming and consulting to support study design and planning.
Regulatory Strategy and Product Development
Support for navigating regulatory landscapes, including regulatory intelligence, global strategy, and submissions for IND, NDA, orphan drug designation, and pediatric investigation plans.
Clinical Pharmacology
Design and conduct studies to assess pharmacokinetics and pharmacodynamics, including first-in-human studies, population PK, simulation and modeling, and clinical trial simulation.
Preclinical Capabilities
Conduct in vitro and in vivo studies to support early drug development.
Clinical Trial Design
Design clinical trials including first-in-human, dose-escalation, and proof-of-concept studies.
Data Management and Analysis
Provide accurate and timely data management and analysis to support decision-making and regulatory submissions.
Biostatistical Programming
Offer biostatistical programming and consulting to support study design and planning.
Services
Clinical Development Services
End-to-end clinical development support including protocol design, dose optimization, Phase I–III trial execution, and study start-up/site intelligence.
Clinical Pharmacology and MIDD
PK/PD study design, translational DMPK strategy, PopPK, exposure–response modeling, and simulation to inform dosing and regulatory submissions.
Regulatory Strategy & Submissions
Regulatory intelligence, global regulatory strategy, CTD/IND/NDA/MAA authoring, orphan drug designation support, and interaction with regulatory agencies.
Drug Safety & Pharmacovigilance
Design and implementation of pharmacovigilance programs, post-marketing surveillance and PASS studies, and medical information support.
Biostatistics & Statistical Programming
Biostatistical consulting, analysis planning, and statistical programming services that integrate with sponsor teams to support study design and regulatory submissions.
Government & Public Health Services
Clinical research services tailored for government-funded studies, including contract negotiation, compliance support, and reporting requirements.
Clinical Development Services
End-to-end clinical development support including protocol design, dose optimization, Phase I–III trial execution, and study start-up/site intelligence.
Clinical Pharmacology and MIDD
PK/PD study design, translational DMPK strategy, PopPK, exposure–response modeling, and simulation to inform dosing and regulatory submissions.
Regulatory Strategy & Submissions
Regulatory intelligence, global regulatory strategy, CTD/IND/NDA/MAA authoring, orphan drug designation support, and interaction with regulatory agencies.
Drug Safety & Pharmacovigilance
Design and implementation of pharmacovigilance programs, post-marketing surveillance and PASS studies, and medical information support.
Biostatistics & Statistical Programming
Biostatistical consulting, analysis planning, and statistical programming services that integrate with sponsor teams to support study design and regulatory submissions.
Government & Public Health Services
Clinical research services tailored for government-funded studies, including contract negotiation, compliance support, and reporting requirements.
Expertise Areas
- Clinical trial management
- Clinical pharmacology and MIDD
- Regulatory strategy and submissions
- Biostatistics and statistical programming
Key Technologies
- Model-informed drug development (MIDD)
- Population PK (PopPK) modeling
- PK/PD analysis
- Clinical trial simulation