A recent investigation published by JAMA found that the average cost of bringing a new drug to market is $1.3 billion. Considering only 12% of new pharmaceuticals receive FDA approval, developing these products requires large amounts of money and even more risk.
To help speed up the drug development process and cut costs, many pharmaceutical companies utilize contract research organizations (CROs). Partnering with an experienced CRO offers many benefits, including reduced expenditures, the ability to handle increasingly complex clinical trials, and quicker time to market. But in order to reap these rewards, it’s critical you establish a strong working relationship.
If you’re preparing to outsource some or all of your development processes, now is the perfect time to focus on building a connection with your CRO. When you’re on the same page and regularly in touch, it’s possible to avoid common pitfalls and achieve the ultimate goal: an effective pharmaceutical that improves the lives of others.
To make the journey a little less challenging, we’ve compiled a list of tips for establishing a healthy relationship with your CRO. By incorporating these suggestions into the connection-building process, you can ensure the drug development process goes smoothly.
1.) Clearly define your expectations. Outsourcing certain aspects of the drug development process requires you to put your trust in an external organization. Therefore, it’s crucial everyone is on the same page and adheres to the same set of rules for all processes and procedures.
At the beginning of your collaboration, sit down with representatives from the CRO. Explain your goals and expectations for the partnership, including how often you expect to meet, your preferred method of communication, and what you hope to achieve. In addition, discuss your company’s values and culture and explain how they guide the work you do.
2.) Establish official points of contact. Strong communication is one of the most important aspects of successfully bringing a new pharmaceutical to market. If questions or concerns arise, you need a point of contact who’s able to respond exactly when you need them. A third-party vendor oversight firm may prove very beneficial in this capacity.
During your initial sit down, designate at least three people from each organization who can take on this responsibility. Explain the importance of their role and collect their contact information, including phone numbers and email addresses. Put all of the contact information together and share it with every member of the team. That way, if an issue comes up, you can take action right away.
3.) Regularly check in with the CRO. It’s important to let the CRO do their job, but you don’t want to take an entirely hands-off approach either. Remember: this is a partnership. For things to go as planned, both parties need to give and take.
To facilitate this process, set up a virtual or in-person meeting at least once a week. If that’s not possible, plan for something every other week. At each meeting, check in with your points of contact at the CRO. Find out how things are going and if there are any parts of your work relationship that need to be adjusted.
If your contacts aren’t very forthcoming, consider creating a digital survey with Google Forms. That allows them to answer your questions on their own time. It eliminates some of the pressure and encourages honesty. Take the time to read their responses and make changes as necessary.
4.) Stay positive. Bringing a new drug to market is a lot of hard work and challenges will inevitably arise. Even so, it’s important to stay positive and have a good attitude. When interacting with representatives from the CRO, always be warm and polite. Be open to their ideas and suggestions and encourage every member of the team to speak up and share their opinions.
If you encounter a bump in the road, it’s not the end of the world. As long as you make an effort to correct mistakes and keep the necessary stakeholders informed, things will work out, even if it’s not necessarily how you envisioned them.
5.) Show your appreciation. CROs work hard to build teams that feature highly qualified scientists and technicians. And they have to go above and beyond to make sure they’re in compliance with federal regulations and ICH GCP standards. It’s a lot of time-consuming, meticulous work that often goes unnoticed. If you want to foster a strong working relationship, take the time to thank your CRO partners. If you’re pleased with the outcome of their efforts, let fellow businesses and colleagues know.
By following these 5 simple tips, it’s possible to build a strong, lasting relationship with your CRO. Do you have a suggestion you’d add to this list? If so, we’d love to hear your thoughts! Fill out the comment form below and then click “submit.”