By John Carlos Diaz, GeoSera Consulting
Clinical research is incredibly complex, and most pharma/biotech companies outsource a lot of the trial oversight responsibilities to contract research organizations (CROs). The increasingly level of complexity and global nature of clinical research has led to poor communication within pharma and between sponsors and their CROs.
I previously proposed five rules to create a strong sponsor-CRO relationship that touch on creating efficient communication between sponsors and CROs:
- Know your contract so both sponsors and CROs can be held accountable for tasks.
- Establish clear roles and responsibilities.
- Create clear and realistic timelines and milestones.
- Distinguish between “nice to have” and “have to have.”
- Foster a symbiotic relationship and team mentality between sponsors and vendors.
Building on the five rules above, I have more specific communication tips to improve the flow of information from sponsors to CROs.
- Email use
- Email is only to document decisions, not to carry on conversations.
- If email is to be used to communicate, emails should be concise and in bullet point format.
- Teleconferences are the best way to communicate complex decisions and to ensure that all parties understand the next steps forward.
- Use the technology available
- Instant messaging
- Video conferencing
- Mobile technology
- Have clear roles and responsibilities for the sponsor and CRO.
Guidelines For Using Email
For my clinical research colleagues that work at large, global pharmaceutical companies, how many emails do you get per day? 100? 200? How many of these emails need to be saved for future reference or to document a decision? 10? 20? I bet no more than 10 per day or 50 per week.
For my clinical research colleagues who work at small companies that outsource a large amount of the work to CROs/service providers, how many emails do you get per day? 200 or more? Again, I bet no more than 10 emails per day are important enough to save for future reference.
The best way to improve communication from sponsors to CROs is to reduce email communication but improve the quality of communication. If an email thread has more than three or four emails back and forth, have a quick teleconference. Emails should be used to document decisions and summarize action items. The amount of time that you can save by having a 3 to 5-minute call instead of multiple emails back and forth will make the communication more efficient, resulting in less confusion on how to proceed during a clinical trial.
If emails must be used, keep the emails short and concise. Bullet point emails with clear, decisive text that leads no room for confusion will ensure that the sponsor’s direction is received by the CRO. If the decisions from the sponsor are clear, the CRO will have an easier time executing those decisions.
Use The Technology Available To Improve Communication
Many of our clinical research colleagues do not use the current technology to improve communication. I consult for multiple types of companies, including small and large pharma, both global and U.S.-based; U.S.-based and global CROs; virtual companies where there is no office; and clinical research service providers where employees are constantly traveling to various locations to train research staff. Regardless of type, the best way to harmonize communication across multiple different companies is to use the three simple technologies that everyone possesses today.
Use Skype for both video conferencing and instant messaging.
Skype is free. Let me repeat that: Skype is free. I cannot think of anything in clinical research that is free, yet so few companies use Skype to improve communication. Using the instant messaging (IM) feature on Skype allows users to have quick conversations to drastically reduce emails. As discussed earlier, how many emails are important? Five percent? Ten percent? Using the IM feature allows two people to discuss nonessential issues quickly without clogging their inboxes. I specify nonessential issues, because emails should be used to document decisions that are essential.
Opponents of IM will state, “we need everything in writing for quality assurance and compliance,” or “what about the audit trail?”, or “we need to document communication outside the company.” No, no, and no. First, you do not need every piece of communication for quality assurance. Again, you need to document decisions only. Second, you absolutely do not need an audit trail for simple, nonessential communications like “be right back.” Third, you do not need to document every communication outside the company. You cannot document phone calls unless you follow up with an email, and even that email documentation is secondhand because the firsthand communication is what was discussed on the phone.
Finally, I am a huge proponent of IM when working with colleagues who are proficient in English but are not native English speakers. IM allows my global colleagues to type in English, even if their English is not strong. I joke with those colleagues when they apologize for not speaking proper English, saying, “Please do not apologize…. your English is much better than my German/Polish/Hungarian/Italian/etc., so I do appreciate you speaking in my native tongue to improve communication between us. You do not want me speaking German/Polish/Hungarian/Italian/etc.”
Using IM will drastically cut down on emails, focus communication, and allow for quick questions and answers so that if there is any confusion, it can be cleared up quickly. IM is a free internet-based service in which all the parties need is an internet connection to improve communication.
Skype has free video conferencing capabilities.
Personally, I do not need face time with a client or colleague, but I know that I am in the minority in this matter, so I agree to have video conferences when others desire it. One way that video conferencing improves communication is that it puts a face to a name/voice. People tend to make more of an effort at civility when they have put a face to a name/voice. If communication across companies is symbiotic, which can result from improved face time, then the team is more likely to succeed.
Use mobile technology.
I have Skype, WhatsApp, email, and, obviously, phone and text capabilities on my mobile phone. I am always available for questions from a CRO or pharma company. Due to the global nature of clinical research — with multiple teams spanning multiple time zones — it is incredibly beneficial to make decisions quickly because the number of overlapping work hours are few. Using mobile technology allows decision makers to make decisions quickly without having to be in front of a computer, ensuring that work does not slow down.
The opponents of using mobile technology to improve communication will state, “I do not want to be available 24/7.” They are right. No one should be forced to be available for 24/7 communication, but using mobile technology to answer quick questions to improve communication allows you to step away from the office or computer and still get work done. I have taken many teleconferences and Skype meetings while taking a walk on a nice day, running, or exercising on an elliptical trainer so that I am still focused on working while keeping myself healthy. Obviously, if my utmost attention is needed on a scheduled teleconference or video conference, I would need to be in front of my computer to focus on the scheduled appointment. By using mobile technology to make yourself more available, it shows your colleagues that you are flexible enough to make decisions properly, so they can continue their efforts without slowdown.
Set Up Clear Roles And Responsibilities
It is imperative for efficient communication to create clear roles and responsibilities for both the sponsor and CRO or vendor in each trial. By using the contract language, the sponsor can create a solid list of tasks that become the responsibility of the vendor. The responsibilities must be easily accessible and not buried in an extensive plan that is not referenced frequently. Each sponsor conducts its trials differently from others, so documenting roles and responsibilities will make it clear to the CRO what tasks are its responsibility. These roles and responsibilities need to be clearly communicated to your vendors.
Improving communication between sponsors and CROs is quite simple, because the tools are readily available to every person in clinical research. While it may sound counterintuitive, reducing the number of emails will improve communication. Reducing emails to only the essential ones will allow colleagues to focus on actual work instead of reading multiple nonessential emails. Also, increasing teleconferences will allow both sponsors and CROs to ask questions in real time, while further reducing confusion. Quick phone calls can save numerous emails and confusion. Instant messaging, video conferencing, mobile technology (phone and text) make it easy to get quick decisions answered in real time, thus not slowing down productivity of the clinical team.
About The Author:
John Carlos Diaz has been in the pharmaceutical industry for 18 years with operational experiences ranging from preclinical drug metabolism and pharmacokinetics (DPMK), clinical pharmacology/Phase 1, adult/pediatric, global Phase 2 to 4, and investigator-initiated trials for both large and small pharma. Currently, John Carlos uses his knowledge of clinical research and drug development to benefit multiple parties within clinical research such as pharma/biotech companies, clinical research sites, clinical trial service providers, and CROs.