Many industry observers have said there's no such thing as a straightforward pharmaceutical development program anymore. Rising costs, high competition, novel therapeutic targets with complex biology and an increase in regulations are all factors that contribute to the challenges of progressing drugs to the market.Despite these concerns, Evaluate Pharma suggest the long-term outlook remains positive and improving the efficiency of Research and Development (R&D) is more important now, than ever. As the industry landscape continues to evolve, so should your relationship with key partners like contract research organizations (CROs) to help you keep the momentum going.
A CROs ability to work and collaborate with organizations to drive and influence the success of the development of novel therapies using agile processes is now often more significant than simply the cost associated to carry out studies. It’s as much about the need for the CRO to become an extension of your team, to provide transparency and high-quality project management than having the scientific knowledge and service portfolio.
With so much emphasis on the Biotech-CRO association, how can you get the most out of your CRO partnership, so it’s one less thing to worry about in the already complex, timely and expensive therapeutic product development process?
1. Plan early and promote transparency with your CRO
Most drug development strategies will begin with the same thing in mind – the end. Follow best practice, be proactive in your approach and have a clinical strategy in mind before enlisting a CRO. Not only will this ensure that the data provided by the program of work are sufficient to support the approval of your Investigational New Drug (IND) or Clinical Trial Application (CTA), it will also reduce the risk of delay in getting studies off the ground.
Here are some of the conversations you should be having with your CRO from the outset to avoid any delay:
- Can your molecule be developed as a medicinal product?
- Has any previous non-clinical work been carried out?
- When will appropriate test article be available?
- Has all preliminary work been shared?
- Is the regulatory pathway understood?
Ultimately, the more information you can share about your therapeutic, the more effective your CRO interactions will be. It's better to be upfront about any concerns or issues earlier in the development program — the likelihood is the CRO has already experienced a similar situation and may suggest a solution. Something that may be keeping you up at night, might not be such a problem after all!
2. Think win-win
When working with a CRO, have a win-win relationship in mind. Focus on understanding the needs and constraints of each other and take advantage of each others specialized knowledge. This is a fantastic foundation for an effective strategic partnership that is devoted to each other’s success. Work together to become more cost effective, reduce risk and ultimately get drugs to market sooner.
3. Define roles and responsibilities
A partnership means different things to different people. Ensure you define roles and responsibilities from the outset and assess the level of ownership and accountability of everyone involved in the work.
This is also a good opportunity to get to know the Study Directors, Customer Relationship Managers, Scientific Leadership and any other personal you’ll be working with on the studies. Share your motivations, challenges and goals with them, not just those of the organization as a whole but each person involved. This will contribute to creating a deeper relationship overall as they’ll have a better understanding of your team’s rationale for working in a certain way.
4. Ensure you communicate regularly
Timely communication as part of the project management process, is an important factor in getting the most out of your CRO. Set your expectations about communication early on – do you want daily, weekly, monthly updates? How will you communicate? Over the phone, by email, face-to-face? It seems simple enough but defining this level of communication early on means everyone involved knows what is expected going forwards.
A key component of delivering projects on time and to budget is to be able to report progress to senior management and meet expectations of internal stakeholders. This timely communication with your CRO will inevitably help you address those needs, drive decision making and prioritize.
5. Don't save all your lessons learned for the end of the project
It’s important to reflect on the journey of your program of work and outline the successes and challenges, but don’t wait until the end to do so. Spending a little time assessing performance at defined project milestones will not only improve quality of the feedback as it’s fresh in people’s mind, it’s also serves as an extension of point two, communicating regularly to get the most out of your CRO.
Moreover, take a deep dive into the why and how of what went on during the project. Were there unexpected costs driven by scope changes? Did some experiments fail that led you to work on a back-up plan for the future? Be sure to not only identify problems you encountered and how you solved them from a scientific and operational perspective, but from a project management standpoint too.
Lastly, celebrate success! Lessons learned are not just about stressing what could have been improved, they’re about highlighting what worked well and how these successes can be implemented elsewhere going forwards.
6. Aim to create a strategic partnership based on trust and collaboration
If you’re already working with a CRO, ask yourself this – do you consider your organization to have a good working partnership? Now, do you consider yourself to have a strategic partnership?
The idea of building a strategic partnership where goals and objectives are shared, enables both organizations to promote a one team approach, creating value together through increased efficiency and alignment. These strong, united relationships help to form trust, which is of course the basis of any good relationship. Focus on educating your CRO about your goals and objectives to build trust and collaboration to help you get the most out of your interactions.
Here, we’ve outlined six major factors you can work on to get the most out of your CRO. Be sure to put this into practice as you navigate the drug development process!