Altasciences
A One-Stop CRO/CDMO Model for Early-Phase Drug Development

Traditionally, drug development has required that drug sponsors leverage the expertise of multiple CROs and CDMOs to complete their R&D. This meant numerous contract negotiations, and data, project and methodology transfers. The entire process was time-consuming and prone to error, prolonging R&D timelines. Not to mention issues like barriers to communication and the burden of project management resting on the sponsor.

That’s why Altasciences’ integration of all the services needed for early-phase drug development under one umbrella was a welcome solution to sponsors worldwide. The company has removed the need for multiple service providers and contracts, eliminating bottlenecks, reducing hand-offs, closing communication gaps and minimizing the risk of errors.

“We have disrupted the CRO model,” says Steve Mason, Co-Chief Operating Officer at Altasciences. “Unlike other CROs, we built a one-stop solution for sponsors to seamlessly advance their molecules and help them bring better drugs to patients, faster,” adds Marie-Hélène Raigneau, Co-Chief Operating Officer.

With CRO and CDMO services handled by one organization—in-house at Altasciences—operational silos and inefficiencies are removed, allowing for data to flow seamlessly and efficiently between teams, sites and phases. This provides sponsors with an efficient and accelerated outsourcing experience—from discovery and lead candidate selection to clinical proof of concept and beyond.

Altasciences’ unique model optimizes efficiency and delivers substantial time savings without compromising the integrity of the drug development process.

The company can anticipate and resolve any situation that might impact the course of a sponsor’s project. The outcome is a results-driven exchange of information that reduces complexities, mitigates risks, condenses timelines and enables cost savings. Altasciences has the great advantage of partnering with many different sponsors and researching their drugs at the beginning of their development journeys, and throughout the initial key milestones. Given Altasciences’ end-to-end oversight of a sponsor’s program, its experts are able to mitigate potential risks and roadblocks from the outset.

Unlike other CROs, we have built a one-stop solution for sponsors to seamlessly advance their molecules and help them bring better drugs to patients, faster

Furthermore, the company has a unique organizational structure, with all scientific teams reporting to two co-chief operating officers to ensure harmonization and collaboration across services. Proprietary systems have been built to ensure optimal information sharing, fueling the teams’ ability to collaborate on multiple aspects and phases of a client’s project.

One great example of Altasciences’ successful integration of solutions is with a client that was experiencing challenges with the split-CRO model, with their preclinical and clinical work being conducted by two different CROs. The client had to wait for the preclinical CRO to complete their portion of the project before submitting an IND application for the clinical work to begin. As a result, the two CROs failed to meet the client’s timeline. When the client turned to Altasciences and its synchronized approach for preclinical and clinical research, the CRO/CDMO was able to develop the client’s IND application and Investigator’s Brochure simultaneously with certain clinical activity. In addition, the company utilized the Health Canada regulatory pathway to fast-track its timeline. In the end, Altasciences was able to reduce the client’s timelines by 10 weeks, meeting their milestones with ease.

For almost 30 years, Altasciences has been scripting many such success stories. Altasciences’ integrated, fullservice solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, drug formulation and manufacturing, program management, medical writing, biostatistics, clinical monitoring, data management, and more—all customizable to specific sponsor requirements.