Optimizing for Success: How Sponsors Can Overcome the Challenges in Early-Phase Drug Development
The Challenges With Outsourcing Drug Development
In a Biopharma Dive survey, 45% of the over 143 biopharmaceutical executives surveyed cited the inability to adhere to tight deadlines as a common challenge in preclinical and Phase I clinical development. Additionally, 50% stated that multiple contract negotiations were another significant pressure point, while 29% attributed miscommunications in project management as a cause of frustration. When transitioning from preclinical to Phase I clinical development, one executive was quoted as saying: “Communication issues… we discuss the project with multiple people, often repeating information or getting different answers.”
How Altasciences Optimizes Early-Phase Drug Development
In contrast to the traditional CRO model, Altasciences provides truly integrated lead candidate selection to clinical proof of concept solutions, including the full array of CRO services. This CRO/CDMO considers the entirety of a drug development program from the get-go, rather than reacting on a phase-by-phase basis. Altasciences’ thorough in-house capabilities and Proactive Drug Development approach provide sponsors with a more enjoyable experience and allows them to reach key decisions sooner.
What Drug Sponsors Can Expect From Altasciences during drug discovery and development
1. One Contract
Sponsors receive one contract for all their early-phase drug development needs, for quicker study start-up and coordinated invoicing and finance activities—and less administrative burden.
2. One Point of Contact
Imagine the convenience of having a single point of contact guiding you through each step of drug development, from preclinical to early-phase clinical studies. A program manager works closely with sponsors from the beginning to understand their unique needs and objectives, and deliver tailored solutions that meet their requirements.
3. Less Repetition
Tell Us Once™ is Altasciences’ commitment to communication. Ask Albert is the proprietary database behind the commitment, fueling integration and facilitating information-sharing across departments, sites, and phases. As a molecule advances, so does our clients’ information; eliminating the need for clients to repeat themselves at each stage of the process.
4. A Clear and Proactive End-to-End Strategy
Each sponsor’s project begins with a comprehensive regulatory and scientific roadmap. Given Altasciences’ end-to-end oversight of a sponsor’s program, its experts are able to mitigate potential risks and roadblocks from the outset.
5. Customized Roadmaps
A cross-functional team builds a unique roadmap designed to adapt easily as the project evolves. Thanks to Altasciences' full-service offering, key activities and studies can occur in parallel and significantly streamline timelines without compromising study safety or integrity.
6. Flexibility in Real Time
With a proprietary centralized scheduling system, Altasciences’ experts actively monitor and manage a sponsor’s study information, results, schedules, sites, and personnel for seamless transitions from one milestone to the next.
In Summary
Altasciences works as an extension of their clients’ team, virtually eliminating the need to manage hand-offs and data transfers at each milestone. We expedite decision-making by aligning early-phase services through communication, customized processes, and integrated platforms and teams. With this approach, sponsors can experience up to 40% timeline reductions. The result is less management by sponsors, coordinated transitions, reduced hand-offs, and transparent information sharing. So, to answer your question about how to best optimize your early-phase program? It’s simple—contact Altasciences.