Choosing the right CRO as a partner for your drug development programs is a vitally important step to achieving critical decision making early on for important milestones, and ultimately getting your molecule from discovery to market efficiently. Building a long-term relationship with a CRO partner that shares your vision and understands your goals, and offers flexible, fully integrated services to support you, is a winning proposition for both sponsor and CRO.
Some Things to Consider in Selecting a CRO Partner
First, you need to understand what you and your team expect and require from your CRO partner. Here are some points to consider, and questions you may ask:
Size. Do you want to work with a large company, or would a smaller one suit you better? Bigger is bigger… period. Do you value personal contact and having a voice in your projects? In many cases, mid-size companies may be more flexible, more agile, and open to adapting their processes to yours. The culture of a mid-size organization usually emphasizes responsiveness and relationships, regardless of the size of your organization or program budget.
Integrated processes and services. Will you have to move your program to a different CRO from milestone to milestone as you advance through the development continuum? Does the CRO have a broad range of support services available to start your molecule off right, and ensure it stays on track? Finding a CRO that works with you from lead candidate selection to proof of concept, with proven integrated processes, can make your life easier by minimizing handoffs, improving communication, and advancing your program smoothly.
Experience. Does the CRO you are considering offer decades of scientific and operational experience combined with an innovative, creative approach? Do they have regulatory knowledge, and niche expertise? Do they have a strong bioanalytical method development team and a robust list of validated assays? Can they guide you through your drug development needs? Scientists, professionals, technical staff, and management with varied backgrounds and experience (pharma, biotech, CRO) ensures a good understanding of your reality, and your needs.
Proven results. Can the CRO demonstrate successful audits from regulatory agencies around the world, and verifiable contributions to significant drug development programs? Are they known for the integrity of their data? Do they have a reputation for developing realistic timelines which are routinely met? Are they well-regarded by industry, with reputable, relevant awards to their name? A history of scientific publications and visibility at industry conferences and events are also important considerations.
Partnering with a CRO that has a history of successfully managing multi-site studies is another factor. Running a multi-site study requires effective communication, coordination of effort and resources, appropriate and timely sharing of information, and robust processes for sample management. Even if your current program isn’t multi-site, knowing that your CRO has the capabilities simplifies future outsourcing activity.
Being fully supported by your CRO partner involves more than running programs according to your specifications. Having a knowledgeable, experienced partner that will offer regulatory expertise and consult with you on your requirements even before programs begin, and adjust if needed as results come in, is important. Seasoned program managers who follow your project closely, create customized communications, and keep you and the team aligned and informed are an important aspect of the overall offering. With a CRO that understands the process from end to end, and has significant regulatory and varied therapeutic indication experience, you improve your chances to meet your timelines with successful outcomes.
The Final Partnership Decision
Once the decision is made, give your partnership the highest chance of success. Work with your CRO to foster an environment of cooperation and collaboration. Regularly communicate regarding the status of your programs, and look for synergies that can maximize the success and the speed of your program. Altasciences offers all this, and more, and our experts would be happy to explore the possibilities with you – click here to get started!
Our deep expertise and capabilities in a broad range of therapeutic areas encompasses preclinical and early clinical studies for both small molecules and biologics. We can manage your entire program, as well as provide support research services and bioanalytical expertise.
Please see Therapeutic Areas for a fuller discussion of our capabilities and expertise.