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10 Ways to Grow your Site’s Study Pipeline Success Site a guide from Forte Research Systems

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Page 1: GrowStudyPipeline eBook Vsm2-7

10 Ways to Grow your Site’s Study PipelineSuccess

Site

a guide from Forte Research Systems

Page 2: GrowStudyPipeline eBook Vsm2-7

Introduction

What are the best ways to grow your study pipeline? The best strategies leverage an understanding of the motivations and perceptions of the people making the decisions.

On a Saturday afternoon in October at a Site Solutions Summit, hosted by RxTrials Institute (RxTi), two roundtable discussions were held on the topic of “10 Ways to Grow Your Study Pipeline.” I facilitated these roundtables along with Siobhan Rowe from PAREXEL International.

As an organization, we at Forte Research Systems have had the good fortune to work

with many world-class clinical research organizations for more than a decade.

This eBook is the result of the combined wisdom of the participants from the round table discussions, expert advice from some of our associates in the field, and what we have seen work for many of our successful customers.

Because companies don’t make decisions and people do, we know that applying some of the following strategies will help you grow your study pipeline for long-term and sustainable success.

“Companies don’t make decisions. People do.”

Srini Kalluri Founder, President, CEO and Chief Customer Officer at Forte Research Systems

Page 3: GrowStudyPipeline eBook Vsm2-7

iSite Success | Forte Research Systems

Table of Contents

SECTION 1 KNOw YOurSElf

Don’t try to be everything to everyone. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .p. 2

Know your recruitment capabilities. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .p. 4

SECTION 2 DISCOvEr OppOrTuNITIES

Make business development a priority. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .p. 7

Build your network. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .p. 9

Make the Web your friend. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . p. 11

SECTION 3 EDuCaTE prOSpECTS

Leverage current relationships. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .p. 14

Build new relationships. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .p. 15

Develop a digital presence. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .p. 17

SECTION 4 DEmONSTraTE ExCEllENCE

Build a great story. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .p. 22

Stand out! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .p. 25

SummarY: a ChECKlIST fOr SuCCESS

abOuT fOrTE rESEarCh SYSTEmS

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1Site Success | Forte Research Systems

SECTION 1 Know Yourself

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2Site Success | Forte Research Systems

Don’t try to be everything to everyone.

Not all trials are good for you.Instead of taking any trial that comes your way, building expertise in a few therapeutic areas demonstrates focus.

Diversify thoughtfully.When you want to enter new therapeutic areas, start as sub-investigator to build the experience before you go it on your own.

Learn to say “No.”Be honest with yourself. Take on only those trials with which you know you can be successful. You will earn the respect and trust of sponsors and CROs, winning you future trials.

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3Site Success | Forte Research Systems

Less is MoreThe oft-cited adage of “less is more” can be applied to several different concepts, but it is certainly appropriate in the context of study selection by sites. There exists the temptation by some to take on as many studies as possible in an effort to gain recognition among sponsors. However, there are pitfalls associated with this approach if you cannot successfully manage an inflated trial portfolio that puts extensive demands on your available resources. In contrast, a conservative and considerate approach to study selection can achieve greater overall benefits.

Christine Pierre, President of the Society for Clinical Research Sites, a trade organization representing the voice of research sites, and who has more than 20 years of consultation experience with site directors, comments, “Sites are often afraid that if they turn a study down, for any reason, the sponsor or CRO may not come back to the site with future opportunities,” she said. “Nothing could be further from the truth. The partnership between the sites and sponsors and CROs is based on the need for complete honesty from the site regarding their ability to successfully conduct the study with high quality and meet enrollment targets.”

“Sites are often afraid that if they turn a study down, for any reason, the sponsor or CRO may not come back to the site with future opportunities...Nothing could be further from the truth.”

~ Christine Pierre, President, Society for

Clinical Research Sites

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4Site Success | Forte Research Systems

Know your recruitment capabilities.

Recruitment is critical.• Keep a central database of all your patients and volunteers.

• Track a few essential characteristics such as DOB, gender, diagnosis, etc.

• Leverage a wealth of information contained in EMR systems.

Conduct robust feasibility evaluations.• Use your database to estimate your ability to recruit.

• Have an idea of your ability to attract new patients through referrals and advertising.

Be in the 20%.• Only 20% of the sites deliver on their recruitment targets. Be one of them.

• Under promise and over deliver!

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5Site Success | Forte Research Systems

“It is critical for today’s sites to use technology to their advantage to identify and contact potential subjects.”

~ Adam Chasse, MHA, Chief Operating Officer, RxTrials

Build a Patient RegistrySites benefit from building a patient registry so they can quickly and easily generate their own call or email lists for recruitment campaigns. A good registry will help sites identify patients who may be suited to the requirements of a proposed protocol using search tools that can match protocol requirements to patient information. With this data on hand, sites can spend their time reaching out to potential patients rather than gathering contact information.

This process is even more streamlined when the registry is integrated with a clinical trial management system (CTMS). Two systems with integrated patient registry functionality are OnCore eClinical and Allegro CTMS from Forte Research Systems.

Leverage Electronic Medical Records (EMR) SystemsSites can leverage a wealth of information contained within electronic medical record (EMR) systems. If used appropriately, this information can be very useful in study recruitment efforts. Successful sites reach out to their Hospital Medical Records team for access to their EMR system and for help developing protocol-specific searches in order to find patients with specific diagnoses and meeting other requirements such as age range.

Depending on the EMR this can be fairly straight forward. For some systems, a good understanding of the billing codes (e.g. ICD-9 or ICD-10 codes) is required. Some sites choose to retrieve this information and store it in a separate patient registry for easy access.

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6Site Success | Forte Research Systems

SECTION 2 Discover Opportunities

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7Site Success | Forte Research Systems

Make business development a priority.

Build business development competencies.Someone at your organization should be taking time to work on locating new studies every week.

Use consultants, if required.• If you don’t have internal resources, use consultants who get paid for results.

• Make sure the people doing your business development clearly understand your site’s capabilities and interests.

Work with external organizations.• Organizations like Investigative Site Networks can help find ideal studies for your site.

• Make sure you have clearly communicated your site’s expertise and interests.

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8Site Success | Forte Research Systems

Understanding the Nuances of Business DevelopmentBusiness development can be difficult for sites, especially those that have little experience. It takes significant lead time and effort to nurture contacts and to convert those to study leads. After that, it takes even more time and effort on the entire site’s part to make the right impression on the sponsor/CRO to ensure those leads become awarded studies.

There are no “magic bullets” for obtaining studies. To help sites understand the many variables involved with this process, RxTrials offers business development workshops for their client sites.

Business development for sites involves not just crafting the right marketing message based on past performance and other site attributes, but also tailoring that message appropriately for whomever you’re talking to at the sponsor/CRO —whether that’s the Vice President, the most junior team member, or anyone in between. What resonates with one may not resonate with the others, so sites need to focus on what’s important to that person’s primary function.

“Get to the right person and sell yourself. Talk about your database, recruitment capabilities, number of doctors, certifications of coordinators, etc. Get the keywords out that you have a quality database and methodology.”

~ Site Solutions Summit Roundtable Attendee

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9Site Success | Forte Research Systems

Build your network.

Build relationships with other sites.By networking with your colleagues at other sites you can create mutually beneficial relationships.

Leverage your current study contacts.• Stay in touch with good monitors. They tend to move up in their organizations. They

may refer you to others.

• Build a database using your study contact lists from the sponsors. This will be a great source to inquire of new opportunities.

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10Site Success | Forte Research Systems

Maintain a Contact Database and Track ActivitesSuccessful research sites keep good lines of communication with their sponsors

and CROs and are continuously looking for new research opportunities. A

centralized location for managing not just contact information but also for

tracking activities, interactions, and documents can greatly increase their

quantity and quality of trials available to you.

“We instituted an exit interview program to market what our site can do beyond what the monitors expect or already know.”

~ Site Solutions Summit Roundtable Attendee

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11Site Success | Forte Research Systems

Make the Web your friend.

Use public databases of trials.• Routinely review trials on CenterWatch and follow up on interesting studies.

• Review Phase I trials on ClinicalTrials.gov. This can give you leads for potential Phase II opportunities in the future.

Pharma web sites are terrific resources.Most pharmaceutical companies list their pipeline along with the phase each product is in on their websites.

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12Site Success | Forte Research Systems

Finding Trials is the First StepThere are plenty of good sources to find trials. Many Site Solutions Summit

attendees use google alerts, pharmaceutical company websites, online news

services, and other means to learn of potential new studies. Then, it’s a matter

of networking in the right way, with the right person, at those companies.

Adam Chasse, MHA, Chief Operating Officer at RxTrials points out, “It’s that

subsequent relationship that should keep the trials coming, but many sites need

help understanding how to go about building those.” To assist sites with gaining

these skills, RxTrials offers workshops on business development.

Donna Benson, of British Columbia, Canada, finds that she can secure one or two studies a month by following up with studies she finds on CenterWatch.com. “The trick is keeping up with the routine. About 75 percent of the time, they say, “We’re only running these studies in the U.S.”

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13Site Success | Forte Research Systems

SECTION 3 Educate Prospects

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14Site Success | Forte Research Systems

Leverage current relationships.

Is the Principal Investigator (PI) engaged?• How available is the PI to the monitors?

• PI engagement goes a long way to get repeat business and new referrals.

Do you treat monitors well?• Being prepared before the visit makes the monitor’s job easy.

• Treating monitors with courtesy makes them remember you when asked for references for new opportunities.

• Simple gestures mean a lot. This can include such basics as offering beverages like tea or coffee, providing sufficient, uncluttered work space, and volunteering information such as the location of the nearest rest room.

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15Site Success | Forte Research Systems

Build new relationships.

Attend conferences.Do you routinely attend conferences such as Site Solutions Summit? These are great avenues to learn about new opportunities, make contacts, and build partnerships.

Follow-up!• Stay in touch with people you meet.

• It can’t be all about you. Offer them something they care about such as an SOP, or advice.

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16Site Success | Forte Research Systems

Networking is not a Spectator Sport

When attending events like Site Solutions Summit, Adam Chasse of RxTrials

points out, “If you are waiting for sponsors/CROs to approach you at a

conference, just remember there are lots of sites being more proactive about it

than you are. These are busy people, and you need to make the first move.”

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17Site Success | Forte Research Systems

Develop a digital presence.

Have a great website.• Build a website that clearly describes what you do.

• Use the right keywords so your website shows up in Google™ searches.

Participate in Social Media.• Do you have a LinkedIn® account and a company LinkedIn page?

• Are you networked with your peers who have a similar focus in therapeutic areas?

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18Site Success | Forte Research Systems

Divide and Conquer: Focus on your Website and on Social Media SeparatelyFacebook, Twitter, Pinterest, blogging, your website… with so many interactive options available for users today, planning an online strategy to reach the right audience may seem overwhelming, at first. Jennifer Whitlock, Vice President at Clinical Site Services (CSS), a GlobalSite Performance Company with services focused on managing the clinical trial patient enrollment process, points out that focusing your efforts in two key areas—your website and social media—can help make this a more manageable endeavor.

Your Website Has Two Key Audiences“Designing and writing your website should be done with two key audiences in mind: (1) potential participants and (2) sponsors/CROs,” recommends Whitlock. “You will need to make sure your content and design speaks to both groups, as their reasons for visiting your website will greatly differ.”

Potential Study Participants

For patients who are interested in clinical research, you will want your website to clearly address and explain the following:

• Education• Benefits and risks to participation• Currently enrolling studies• Online submission form• Directions

For examples of patient-oriented websites see: http://www.clinicalsiteservices.com/

portfolio/web.html

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19Site Success | Forte Research Systems

Sponsors and CROs

In trying to reach and appeal to the sponsors and CROs who are viewing your website for possible site selection, you will want to convey the following key points:

• Experience• PI CVs and bios• Regular updates

Other Necessary Content

Overall, your website should also include:

• Company news• Events• Keyword-dense content

Social MediaGaining a foothold in social media can be best accomplished if you keep one key goal in mind: to have meaningful interactions with your audience.

“You want to impact a reader so that your information will be liked, shared, retweeted, commented on, or repinned. Additionally, you want to share information that helps to bring value to your readers,” says Whitlock.

Navigating social media is best done with a focused plan in mind. You can’t be all things to all people, so choose your social media vehicles carefully. You will likely want to choose a few of the more popular outlets such as:

• Facebook• Twitter

“You want to impact a reader so that your information will be liked, shared, retweeted, commented on, or repinned. Additionally, you want to share information that helps to bring value to your readers.”

~ Jennifer Whitlock, Vice President, Clinical Site Services

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20Site Success | Forte Research Systems

• LinkedIn• YouTube• Pinterest

A commitment to providing regular, meaningful content can best be accomplished by developing an editorial calendar to keep you on track. It’s easy to create a Facebook page or Twitter account—the hard part is to feed it regularly!

In SummaryDigital media changes so quickly that it often seems overwhelming if you haven’t included it as part of your marketing activity. Start small, be consistent, and grow your efforts as time goes on. As online activity becomes more and more prevalent in our world, your site will reap the rewards of being a digital leader.

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21Site Success | Forte Research Systems

SECTION 4 Demonstrate Excellence

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22Site Success | Forte Research Systems

Build a great story.

Become a center of excellence.• Do you have well-defined SOPs, trained and qualified staff, and good infrastructure?

• Do you have a centralized database of your past performance on recruitment, quality, safety, and compliance?

• Do you keep metrics that demonstrate your track record?

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23Site Success | Forte Research Systems

Metrics Help Demonstrate Success and Find Areas for ImprovementOn what does your site perform well and where could it improve?This may seem to be a straightforward question that requires a simple answer. But, while an anecdotal response may seem sufficient, sites that rely on experience alone are missing a valuable opportunity to improve their operations and gain a competitive advantage. That opportunity centers on objective measurement of activity across a site to effectively assess where operations are strong or where they are lacking and in need of improvement. These measurements are commonly referred to as metrics.

Metrics tell us about processes.“Metrics” is a business term that, for sites, has almost become synonymous with the mandated collection of seemingly arbitrary data for reporting to CROs and sponsors. However, the true value of metrics relates to their original intended purpose, measuring operational performance in order to improve internal processes. In clinical research this can be highly beneficial when applied where the work is being conducted — at the sites.

According to data collected by the Tufts Center for the Study of Drug Development, about 90% of all clinical trials are delayed due to over-ambitious timelines and difficulty enrolling patients. Further, for the average trial, about 20% of all principal investigators (PIs) fail to enroll a single patient and 30% under-enroll in a given trial. The cost of performance like this to the entire industry in terms of time, resources, and productivity is unsustainable. The

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24Site Success | Forte Research Systems

opportunities to implement performance metrics in order to support continuous improvement strategies at the site level remain numerous.

Because sites conduct so much of the daily work, there is a wealth of information that can be collected about processes such as study startup and patient accrual rates.

Use site-centric metrics to highlight your site’s strengths.In ”A Case for Site-Centric Operational Metrics,” from the August 2012 edition of The Monitor, Henry Durivage, PharmD, et. al. point out the business advantage of promoting a site’s strengths:

“Identifying areas where a site has a very strong competitive advantage can be highly beneficial for securing additional trials and for eliminating wasted effort. For example, a site that has a proven track record in successfully accruing to geriatric trials should advertise this fact when wooing sponsors of trials with this target subject community. Likewise, this site should probably decline participation in pediatric trials.”

Learn more.To learn more about site-centric metrics see, “Pinpoint and Market Your Competitive Advantages with Metrics,” by Linda Sullivan, Vice President of Operations, Metrics Champion Consortium, et. al. at the link below.

http://forteresearch.com/news/pinpoint-and-market-your-competitive-advantages-with-metrics-2

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25Site Success | Forte Research Systems

Stand out!

The Study Feasibility Questionnaire is an opportunity.• Do you fill out all the requested information?

• Do you provide supplemental information that showcases what a great site you will be?

Get noticed!• Do you attend conferences and share your expertise with others?

• Do you participate in online dialog through writing blogs or at least commenting on them?

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26Site Success | Forte Research Systems

Summary: A Checklist for Success

✓✓ Don’t try to be everything to everyone.

✓✓ Know your recruitment capabilities.

✓✓ Make business development a priority.

✓✓ Build your network.

✓✓ Make the Web your friend.

✓✓ Leverage current relationships.

✓✓ Build new relationships.

✓✓ Develop a digital presence.

✓✓ Build a great story.

✓✓ Stand out!

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27Site Success | Forte Research Systems

About Forte Research SystemsWe have been providing systems that support excellence in clinical research operations for over a decade. In this time, it has been our good fortune to work collaboratively with our customers as we developed new products and enhanced product functionality to meet the challenges that they face every day. We strive to be the recognized thought leader and preferred provider of innovative solutions that help improve operational efficiency, patient safety, and regulatory compliance.

The OnCore® eClinical solution is specialized to meet the needs of academic medical centers, CTSAs, research hospitals, and cancer centers. In addition to patient registries, biospecimen management, and billing compliance, OnCore offers CTMS, EDC, and data management functionality for the clinical research enterprise managing a robust portfolio of clinical trials.

The Allegro® family of specialized clinical trial management systems are easy-to-use and intuitively designed. Allegro CTMS@Site® is designed for investigator sites and research groups while Allegro CTMS@Network® is designed for multi-site networks and site and trial management organizations.

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Copyright © 2013 Forte Research Systems, Inc.

Forte Research Systems 1200 John Q. Hammons Drive, Suite 300

Madison, WI 53717 (608) 826-6002

[email protected]