Comprehensive Global Clinical Development Solutions | Allucent
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Comprehensive, global drug development solutions

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A-Team Expertise, Tailored for You

As a Contract Research Organization (CRO) focused on the distinct needs of small and mid-sized biotech companies, Allucent has one purpose – helping you succeed across the drug development journey. With experienced professionals who collaborate with you every step of the way, we offer Clinical Development, Clinical Pharmacology, Regulatory Strategy, Safety & Pharmacovigilance, and Government & Public Health Services solutions designed to support your specialized needs.

From early planning to approval and commercialization – and at any stage in-between – our A-Team experts partner with you to provide strategic guidance and thorough, creative solutions to support each important milestone.

Comprehensive Global Drug Development Solutions

How can we support your
drug development journey?

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A-Team
Expertise

Discovery

Early Phase

Late Phase

Post-Marketing Approval

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.

 

Click through the path above to see how.

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.

Once approved, Allucent Consulting™ applies 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.

FAQs

Allucent’s solutions help small and mid-sized biopharma overcome scientific, operational, and regulatory challenges across drug development. This includes designing targeted trials for complex indications, clinical pharmacology expertise for dose optimization, navigating evolving regulations with former regulators’ expertise, tailored strategies for patient recruitment and engagement, and managing clinical data with precision, enabling partners to accelerate development timelines and reduce risk.
Allucent’s tech-enabled environment combines clinical operations with data management and analytics, ensuring that trial design, data collection, and reporting work seamlessly together. This integrated approach empowers teams, improves efficiency, enhances decision-making, and maintains data integrity for regulatory submissions.
Allucent’s regulatory strategy services guide sponsors through global regulatory pathways with insights from former regulators across six regulatory agencies. Services include regulatory intelligence, submissions strategy, compliance planning, and milestone execution, covering pre-submission meetings, expedited pathway designations (Fast Track, Breakthrough Therapy, Accelerated Approval), orphan drug strategy, and pediatric development plans (PSP/PIP).
Yes - Allucent’s tech-enabled safety and pharmacovigilance services monitor and manage drug safety throughout the clinical trials and post-marketing lifecycle. Services include PV system set-up and maintenance, risk management and signal detection, global QPPV and local affiliate services, and expedited regulatory reporting to ensure patient safety and regulatory adherence across global markets.
Allucent has specialized capabilities to conduct government-sponsored and public health research, partnering with leading agencies including BARDA, Department of Defense, NINDS, and NIAID. Our government services A-Team brings the collective expertise needed to navigate the unique regulatory and compliance requirements of this sector while collaborating with agencies to deliver clinical research programs effectively and on time.

Partner With the A-Team

Let us know how we can help you bring new therapies to light. Get in touch to get started.

Join the A-Team

Want to help small and mid-size biopharma companies change the therapeutic landscape?

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