Comprehensive, global drug development solutions
Small and mid-sized biotech companies have distinct development challenges from therapeutic innovations through the clinical process to approval. Allucent offers regulatory, product development, and clinical research solutions designed to support these specialized needs.
From the earliest stages of your planning process, our experienced professionals collaborate with you, providing strategic guidance and thorough, creative solutions. We’ll work in partnership with you to increase your team’s bandwidth throughout your project and support each important milestone.
You won’t find another drug development organization focused exclusively on partnering with small and mid-sized biotech that offers our range of experience:
- 30+ years of worldwide experience
- ~80% small and mid-sized pharma clients
- 825+ regulatory submissions per year
- 500+ clinical trials conducted
- Global reach: trials in 25+ countries
- Expertise in 8 challenging therapeutic areas
Clinical Trial Operations
A collaborative approach is key to bringing the potential of your therapy to light. As your dedicated partner, we offer deep, global experience in clinical trial design and execution covering complex therapeutic areas and challenging indications. Our mission is to complement your internal capabilities with our expertise to support innovation in treatments for patients with unmet needs.
- Protocol Development and Study Design
- Patient Recruitment
- Feasibility and Study Start Up
- Clinical Project Management
- Clinical Operations
- Centralized Monitoring
- Centralized eTMF
- Medical Services
Small and mid-sized companies need a trusted partner to support them with all aspects of data management, clinical data analysis, and biostatistics at any point in the development process. Our rigorous biostatistics services clarify your treatment’s efficacy and safety for regulatory bodies while meeting the data requirements of all clinical trial phases. We prioritize data integrity and efficiency and deliver the highest standards on the most current data platforms.
Regulatory and Drug Development Consulting
Companies like yours come to us for one key reason. You trust the depth and breadth of knowledge we bring to your product development challenges, counting on dedicated support from some of the most respected regulatory and technical experts in the field. We can help you with strategies for regulatory, clinical, nonclinical and CMC development planning, health authority meetings, authoring and submission publishing, and support for GxP compliance and pharmacovigilance services.
- Clinical Strategy
- Chemistry, Manufacturing, and Controls (CMC)
- Nonclinical Consulting
- Regulatory Affairs
- GxP Strategy Consulting
- Publishing and Submissions
- Medical Writing
Clinical Pharmacology Modeling Simulation
Clinical pharmacology is essential for the development of safe and effective drugs/therapies. When utilized appropriately, the clinical pharmacology strategy is a road map to guide an efficient clinical development program. With modeling and simulation, prospectively planning and harnessing data from multiple sources will answer many important questions for your development program including dosing and the value of the drug for patients.
Our specialized focus in Clinical Pharmacology, Model Informed Drug Development (MIDD), Pharmacometrics (PMx) and Pharmacokinetics/Pharmacodynamics (PK/PD) helps our clients improve drug development efficiency and probability of success and avoid costly missteps including the possibility of regulatory rejection.
- Clinical Pharmacology Integrated Drug Development
- Model Informed Dose & Drug Development (MIDD)
- Pharmacometrics, Pharmacokinetics, Pharmacodynamics (PKPD)
- DMPK Discovery and Development
Government Public Health Services
When it comes to your government-funded clinical trial, you won’t find another CRO with more experience working through contract negotiations, compliance issues, reporting requirements, and more.