I was invited to speak on a panel this week at the Outsourcing in Clinical Trials West Coast conference. This was my second year in attendance and the conference was an excellent investment of my time with lots of great networking and informative sessions. The topic for my panel was “Examining mistakes some vendors make when approaching new clients to build and strengthen outsourcing partnerships”.
For the blog, I thought it would be a fun exercise to summarize a few key points brought forth by my fellow panel members. However, I will flip it around by adding my comments on how each of the take-aways apply to our roles as monitors when establishing relationships with new clinical trial sites. I’d also love to have your perspective so please email me at theleadcra@yahoo.com or leave a comment below.
I - Do Your Homework
 |
You don't have to be a total stalker,
but a little internet research will help. |
Our panel agreed that vendors can do a better job of learning about our company background, structure, and culture before they approach. Most companies have a website and a lot of this information is listed there in a Mission Statement, Pipeline overview, Investor Reports, Press Releases, etc. Anyone can google a company for news within the past 12 months and get a good idea of what the current challenges to the business are. You can also
search by sponsor at clinicaltrials.gov to read a lot of details about past and current trials including who to contact, who the investigators are, and basics of the trial design. With this information in hand, vendors can tailor their approach to only offer the services and products that are most likely to be of interest rather than going through the whole dog and pony show.
So as monitors, here are some of my ideas on how you can you better prepare for a
first site visit or any other in-person meeting with your site personnel for the first time. It goes without saying that you should already know all the ins and outs of your protocol, be able to speak intelligently about the drug program, Investigator’s brochure, study tools, and the sponsor before you meet with any site personnel. So let’s focus instead, on what you can now easily discover about the site. Well, presumably you have the CV of the Principal Investigator and some of the key study staff. Figure out when they graduated and where they completed their residency. See where they grew up. Read through all their experience, have you worked on similar studies? Have you visited their home state? Do you have anything in common with their background that you could possibly use as an ice-breaker in the introduction? If they are published, locate titles or abstracts so you know where their research interests are. Consider bringing along a relevant recent journal publication or news article that you can pass along. Google their office or research center to see if they have a website so you can learn more about their practice or recruitment strategies. Are they on facebook, twitter, or other social media sites? Many doctors have been reviewed by their patients on yelp; this can be enlightening. Ask around with other regional CRAs you know who have worked in that therapeutic area if they are familiar with this site or any of the employees. Maybe your company has an investigator database and you can glean some further insights there? Go on clinicaltrials.gov and see what other studies they have done (you may need the location name of the site rather then the PI name to get any results or you can use the
map). Now you can ask about their specific experience in other trials and head off any of those same challenges in yours.
By the way, you don’t have to tell them how much research you did or hint around too much (since you might seem like a stalker) but if you do this homework beforehand, you are going to be more prepared for the meeting and better able to find common ground and guide the conversation, trust me. Since you now know so much about your site, you can easily tailor your communications to their trial experience level so you can be engaging and helpful rather than patronizing, overwhelming, or boring. You’ll have more meaningful dialogue and can probably learn a lot from them when you ask them for more details about their past experiences. Finally, if you put in this time and energy to kickstart a relationship then you obviously respect and admire other people that you work with; that will not go unnoticed downstream.
II - Avoid the Cold Call
 |
| The dreaded cold-call sales pitch. |
On the panel, we all explained that we are busy and our time for vendor selection is limited. We have a very basic expectation that business development people will be sensitive to our time. Now don’t get me wrong, I love free lunch, sticky pads, clickable pens, squishy stress balls, and laser pointers, as much as the next guy, but my time is valuable and if I meet with each and every vendor that calls me out of the blue, my performance at work would suffer because I would run out of time to fulfill my basic job responsibilities. The sad reality for new vendors is that we’re just more likely to work with vendors and people that we have known and worked with before. When I get a cold call and they say “Is now a good time to chat?” If I say “No” that is not an invitation to rattle off 10 bullet points quickly before I put down the receiver. I would rather they say, “no problem, I’ll send a capabilities overview via email and hopefully we can schedule some time to chat after that”. There was consensus on the panel that conferences like ASCO, therapeutic area programs, DIA, ACRP, outsourcing, etc. are a much better forum for getting to know one another rather than the telephone. We also rely heavily on referrals from our colleagues in the industry so please spend less time on cold calls and more time networking for introductions from your satisfied clients for new business. If on the off-chance a vendor catches me on a cold call and I have 10 minutes to chat, I will ask very specific questions about capabilities and metrics used to track performance in similar previous trials and ask particulars about their relationships with other clients. If you call me, I expect that you already know about my business as I work for a publically traded company. Again, they called me so they need to be prepared and have done their homework (see point 1 again). I am not just sitting by my phone all day hoping some random vendor will call me and then ask me to explain what my company is working on; the information is out there.
So you are a CRA assigned to a new site and you were told by your lead to make a site contact within 10 business days. OK, so if you just call out of the blue will the coordinator be pleased to hear from you? Most likely, no. My recommended approach is to send an email introduction first.
“Hi, my name is NadiaBoBadia. I am a CRA based in San Francisco and I’ve been informed that we will be working together on the trial. I am really looking forward to visiting your site next month. I’d love to call and introduce myself to you this week. I’ll try you this Thursday at 10am EST. I also have availability after 2pm and would be happy to phone you at that time or another time if it is more convenient, just let me know. I am hoping we can chat for 10-15 minutes regarding next steps for working on this trial together."
See what I did there? I am 100% planning to call them; they can expect it and prepare for the call. I also provided an alternative time so they know I understand that they have other priorities in their schedule. The way I phrased it, no response nets a call at 10am. If I said, “Should I call at 10 or 2?” and they did not respond I would have been stuck with a cold call. One other benefit of this approach method is that if they are the wrong contact person, they typically write back immediately and let you know right away, which saves a lot of time playing tag.
During your first phone call be sure to ask what method of contact works best. I personally LOVE talking on the phone and I always follow-up with an email summarizing the conversation for a contact report. However, I do understand that exclusively email or even texting is preferred by some coordinators and I accommodate them.
III - Determine the Decision Makers
 |
| Who has the power of the purse strings? |
When CROs, EDC providers, recruitment vendors, lab and imaging vendors, or any other type of outsourcing partner approach a new client, they should determine as early as possible who the decision makers are so they are pitching to the right person; get those people in the room during demos and discussions. On the panel, we all agreed that it is important to navigate the layers within an organization to figure out who signs the contract at the end of the day. Are there folks that need to be won over in legal and contracts in addition to clinical? Many organizations have preferred provider relationships and master service agreements, which represent a barrier for new vendors coming in. Most sponsor companies will require a quality assurance visit or a business assessment before inking a contract with a new vendor. If the vendor can ask the right questions early in the process, they should be able to define expectations around the proposal process in regards to how long it takes and who needs to bless vendor selection and contracts.
As site monitors, we can also benefit by figuring out who is running the show. It should come as no surprise that at many sites, the decision of who gets recruited for your trial (or whether your data is entered into EDC in a timely fashion) is often times up to the coordinator. It really depends on the therapeutic area and how niche the disease state is, but for many studies, it is the coordinator who digs through the patient database and approaches prospective patients with the informed consent. The manner in which the coordinator presents the trial will impact how appealing the study is to a patient and their caregivers. You should test this assumption and find out if the key to your enrollment may in fact lay with your coordinator. Just ask what process they used in the last trial to identify potential subjects. Try chocolate – it helps. Make sure the coordinator is behind your study and likes working with you. The next step is to figure out how to motivate the people whose efforts will contribute to the study goals and milestones.
 |
| It never hurts to show up with chocolate. |
Moving Forward
OK, and this is a little bit off topic, but what about follow-up after the approach? Whether your first meeting was the start of a beautiful relationship and butterflies/rainbows/lilies rose up around you or whether they slammed the door in your face and you were standing in the cold, you will hopefully be working together and want to grow the relationship. Consider sending a handwritten thank you card or small gift. Email a link to an article that might interest them or share a case study or industry tool or website (The Lead CRA blog?) that you have found helpful in a past study. Stay on their radar without being intrusive and your relationship will grow stronger. I’m enthusiastic about working on clinical trials and I love building new relationships. I hope you found some of these tips useful and you can improve your approach when meeting new colleagues in this industry. Share your perspective with me at
theleadcra@yahoo.com or please comment here on the blog.
You may also like...from The Lead CRA archives:
