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)
Allucent
Cary, North Carolina, United States, North America
Services
End-to-end clinical development support including protocol design, dose optimization, Phase I–III trial execution, and study start-up/site intelligence.
PK/PD study design, translational DMPK strategy, PopPK, exposure–response modeling, and simulation to inform dosing and regulatory submissions.
Regulatory intelligence, global regulatory strategy, CTD/IND/NDA/MAA authoring, orphan drug designation support, and interaction with regulatory agencies.
Design and implementation of pharmacovigilance programs, post-marketing surveillance and PASS studies, and medical information support.
Biostatistical consulting, analysis planning, and statistical programming services that integrate with sponsor teams to support study design and regulatory submissions.
Clinical research services tailored for government-funded studies, including contract negotiation, compliance support, and reporting requirements.
End-to-end clinical development support including protocol design, dose optimization, Phase I–III trial execution, and study start-up/site intelligence.
PK/PD study design, translational DMPK strategy, PopPK, exposure–response modeling, and simulation to inform dosing and regulatory submissions.
Regulatory intelligence, global regulatory strategy, CTD/IND/NDA/MAA authoring, orphan drug designation support, and interaction with regulatory agencies.
Design and implementation of pharmacovigilance programs, post-marketing surveillance and PASS studies, and medical information support.
Biostatistical consulting, analysis planning, and statistical programming services that integrate with sponsor teams to support study design and regulatory submissions.
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
News & Updates
Join our upcoming webinar to learn about optimizing dose escalation in early-phase development.
An in-depth look at the new ICH E6 (R3) guidelines and their impact on clinical trial leadership.
Allucent has been recognized as a Great Place to Work, reflecting its commitment to a positive workplace culture.
Join our upcoming webinar to learn about optimizing dose escalation in early-phase development.
An in-depth look at the new ICH E6 (R3) guidelines and their impact on clinical trial leadership.
Allucent has been recognized as a Great Place to Work, reflecting its commitment to a positive workplace culture.