How can we support your
drug development journey?
At Allucent, our A-Team experts are spotlight focused on your needs – and uniquely adept at foreseeing and overcoming the challenges that routinely appear in complex therapeutic areas, indications, and modalities.
We help guide your science through the complexities of drug development to bring needed therapies to light for patients around the world.
Our experts support your distinct needs with:
- Deep experience in critical areas that are often hard to source for smaller companies.
- Therapeutic expertise in complex categories where specialized support is essential.
- The operational prowess needed to help you move forward efficiently and effectively.
- An integrated cross-discipline expert approach, customized to your needs.
- Partnership and collaboration at the center of all we do.
Allucent provides comprehensive support in the identification and validation of your potential drug candidates – enabling you to make informed decisions and advance promising compounds to the next stages of development.
Regulatory Strategy and Product Development. We help you navigate the complex regulatory landscape and ensure successful development and approval of drugs. Expertise includes regulatory intelligence, therapeutic knowledge, global strategy, IND and NDA submissions, orphan drug designation, and pediatric investigation plans.
Clinical Pharmacology. Our deep experience delivers drug development insights through designing and conducting studies to assess PK/PD; First-in-Human studies; PopPK; Simulation and Modeling; and clinical trial simulation.
At Allucent, we deliver expert knowledge, the right global network across more than sixty countries and innovative data-driven solutions to set a strong foundation for complex early studies, and for your subsequent trials.
We deliver a comprehensive set of services to help drive your drug development program.
Strong preclinical capabilities including in vitro and in vivo studies.
Clinical trial design including first-in-human, dose-escalation, and proof-of-concept.
Data management and analysis. Allucent delivers accurate and timely data to support decision-making and regulatory submissions.
Biostatistical programming. Full time statistical consultants provide in-depth support for complex needs and become part of your core team to ensure proper study design and planning.
Collaboration and communication. Regular updates, transparency, and a collaborative approach help ensure great working relationships and success.
Across Phase II-III trials and through regulatory submissions, our global experts work as your partners, applying our insights and customized services to help ensure the highest quality research and improve outcomes.
We work with you to gather comprehensive data on the safety and efficacy of your investigational drugs.
Large-scale Clinical Trial Expertise. We have a strong track record of managing large-scale Phase III clinical trials.
Global footprint. With hundreds of years of experience across Allucent, we have the expertise to conduct multi-center and multinational trials to ensure diverse patient populations are represented.
Study Start-up. Efficient study start-up is crucial to meet project timelines. We pride ourselves on timeliness and speed, site selection and feasibility, risk mitigation, adaptability, and integration of systems and technology.
Patient recruitment and retention. Allucent understands the patient journey and how to ensure enrollment targets are met in a timely manner.
Once approved, we apply our post-marketing study expertise to help you demonstrate the real-world value of your products and collect insights to help make the regulatory case for patients around the world.
Post-marketing Surveillance and Pharmacovigilance. We design and implement post-marketing surveillance programs, including post-approval safety studies (PASS) to monitor the long-term safety and effectiveness of the drug.