Successful Communication between Sites, CROs, and Sponsors

1. Successful Communication between Sites, CROs, and Sponsors Caryn Hussar, MS Site Network Manager, Quintiles

2. Overview • Common barriers to effective communication • Working together to overcome these barriers • Communication best practices and skills • The Who, When, and How of Communication • The GROW technique • Putting skills into practice—scenarios. • Why successful communication is important

3. “The single biggest problem in communication is the illusion that it has taken place.” ~George Bernard Shaw

4. Discussion: think of a situation when there was a breakdown in communication. What caused it? Think about someone with whom you communicate well—what qualities does your communication have?

5. Common Barriers to Effective Communication What gets in the way of our ability to understand and be understood? • Volume • The sheer amount of e-mail, telephone calls, text messages, and instant messages we receive in a day can be daunting. • Sometimes it’s difficult to know what to prioritize when we are “getting hit from all sides.” • Multitasking • We are all so busy that we resort to multitasking out of necessity, even when it’s not the most efficient way to get things done. • Constant interruptions and distractions can prevent us from truly processing information. • Cultural/Language/Mode of Communication Barriers • We work in a global environment. • It’s sometimes difficult to gauge tone from an e-mail, which can result in potential misunderstandings. It’s important to choose the right mode of communication for your message.

6. How can we work together to overcome these barriers? Practical solutions for improved quality of communication in our work environment

9. LISTEN: communication does not just mean speaking, it involves listening. • Pay attention to non-verbal communication, your own and others’. • Know your audience. • The message sent isn’t always the message received. • Get to the point.

11. Tips to remember for good communication • Keep stress in check: • Stay calm under pressure. • Pause to collect thoughts. Use stalling tactics if necessary. • Speak clearly. • Make one point. • Summarize then stop. • Assert yourself: • Value yourself and your opinions. • Know your needs and wants. • Express thoughts in a positive way. • Receive feedback positively. • Learn to say no—Know your limits..

12. The Who, When, and How of Communication Making communication efficient and effective. Who When How • Who can help me? • Study Start-up Team • CRA—your first point of contact • Project Team/Medical Monitor • Site Network Manager • On-site monitoring visits • Site Selection Visits • Site Initiation Visits • Interim Monitoring Visits • Investigator Meetings • Sponsor, Sites, & CRO together • Great F2F opportunity • Day-to-Day • Set aside time • When urgent, don’t hesitate to use the phone • E-mail • Concise and clear (less than 4 sentences when possible) • Provides a trail • Face-to-Face* • Good for involved discussions • Less room for confusion • Phone* • Best for immediate needs or questions that might cause too much “back & forth” in e-mail. • *reminder to document any F2F discussions or phone calls in a follow-up e-mail.

13. WAY FORWARD • Choosing one of more options and working together towards the goal. Action steps.

14. Your CRA has contacted you regarding open queries that need to be closed for a database lock. She is asking that they be done by the end of the day. Your schedule is packed today with seeing patients. How would you approach this situation?

15. You are working on a study in which enrollment has slowed down. The sponsor has asked the CRA to discuss recruitment at your site. One of the issues is that there is an exclusion criteria that is preventing you from enrolling subjects as quickly as the sponsor would like. How would you handle the discussion with the CRA?

16. Your CRA has just been on site for a 2-day visit. When you checked in with him, he said that everything was going fine and didn’t provide any feedback. Several days later, you get a follow-up letter with a long list of Action Items, some of which could have been addressed during the visit. How would you respond to this?

17. Why is successful communication so important? • Our jobs are patient-centric. Successful communication allows us to: • safely care for the patients currently in our studies. • contribute to the development of medications for future patients. • It saves time. • it cuts down or eliminates re-work—helps everyone “get it right the first time.” • it minimizes back & forth e-mails and phone calls. • It prevents frustration. • knowing your “go-to” people will speed up the process to getting answers you need.

18. How else does communicating well benefit me? Good communication skills: • Are sought after • Writing skills • Presentation skills • Are critical for leadership. • Are recognized as part of a manager skill set. • May improve your chances of employment or promotion. • Will set you apart.

19. Summary • We encounter barriers to effective communication on a daily basis. • These barriers to communication can be overcome by working together. • Knowing the who, when, and how of communication will facilitate this. • Successful communication is vital for the best patient care, efficiency, and minimal frustration.

20. Questions?

21. Safety and care of patients are at the center of our core values and everything we do.