THE
EDGE Issue III
Technology & Clinical Trials How mobile applications are changing recruitment. P.04
Reasons To Join A Network How joining a site network benefits your research site P.06
Patient Travel How it increases enrollment & how we can help P.09
www.Clin-Edge.com
137A Lewis Wharf, Boston, MA 02110
CONTENTS 2
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LETTER FROM THE PRESIDENT
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5 APPS THAT ARE CHANGING CLINICAL TRIALS
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9 REASONS TO CONSIDER JOINING A SITE NETWORK
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TRAVEL IS PART OF THE PATIENT EXPERIENCE
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CREATING CONNECTIONS
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SOCIAL MEDIA: Your Clinical Research Marketing Tool
Message from Christian Burns, President of ClinEdge.
Although not all have been released, these apps have the potential to advance patient safety and health awareness.
As competition for studies among research sites increases, site networks are playing a larger role in the clinical trial industry. See why a site network would benefit your research site
We’ve seen it time and again; patients are more likely to follow through with a study when they have reliable transportation to their study visits. Find out why having a reliable and friendly travel program can increase patient retention and help streamline your clinical trial.
Sagely Health is working to transform the way cancer trials find and treat patients. The Boston-based startup has been able to connect patients with doctors and trials.
What’s the best way to break the barrier between a patient and a research study? Find out more about how a social media strategy can help recruitment.
Copywriting & Editing
Design & Direction
Amy Magill Simonne Valdez Doug Cavers Samantha Rogers Nicole Stratton Christian Burns
Georgia Ward Ashley Eldridge Jamie Reddish
Letter From The President
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linEdge and BTC Network have been growing at an exponential rate. Potential clients consistently ask us what sets us apart from our competitors. Of course, we have a list of our advantages in terms of our processes, services offered, and more; however, there is one very specific area that potential clients often overlook. This area is not taught, but it’s a part of every one of our employee’s DNA –
work ethic. We simply outwork our competitors and this is crucial to our success. When it comes to clinical research and all of its stigmas, the difference between us and so many of our competitors is the significant research we conduct to identify game-changing innovations in the industry. Many of our competitors will draw a line in the sand and say, “You can’t do that because it has never been done.” Our entities thrive because we break down barriers and create new paths and opportunities. We believe it’s essential to stray from mediocracy and feel a sense of over-achievement. Success can be translated in many ways. For us, it’s about working hard at whatever it is that fulfils you and giving it 150%, taking the existing world, re-evaluating it and changing it for the better. To us, there is no other way. Nothing happens overnight. Start something that you believe in and stick to it. Get a head start and work hard every single day. Our teams wake up every day excited and with an understanding that we can make a difference. Every day at ClinEdge and BTC Network, individually and as a unit, we challenge ourselves to exceed expectations. We have a real opportunity to build the strongest clinical research company in the world. We believe that it’s not all about winning- losing gives us the opportunity to learn. The game, the process, the climb: that is the drug that drives us. That is our oxygen. It’s what we love.
Christian Burns President, ClinEdge
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5 APPS THAT ARE
Changing Clinical Trials Each of these mobile applications brings the convenience of health services directly to patients through their mobile devices. Although not all have been released, these apps have the potential to advance patient safety and health awareness.
Mood Mission moodmissionapp.com
A new app in development, Mood Mission was created to
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help users learn how to cope and manage their mental health. The app is based on cognitive behavioral therapy (CBT) and psychoeducation, and unlike any other apps currently available, it’s experimentally validated through randomized, controlled trials to test its effectiveness. A user reports their mental health symptoms to the app, and the app recommends 5 coping strategy “missions”. Then, the user chooses one of these mission games, and is rewarded with points, badges, and other achievement acknowledgements. To correspond with CBT, users will report their mental and emotional state after completing missions.
VitalSnap
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validic.com/vitalsnap
It’s like SnapChat, but instead of sending selfies to your health care provider, you’re sending photos of medical device readings! This new app, in development by Validic, stores and organizes a patient’s personal health device information just by taking a picture. After taking a measurement, the patient will snap a photo of their personal medical device screen, and VitalSnap recognizes the device and information, then digitizes it. Instantly, the app stores the information and shares it immediately with the patient’s medical care provider.
Airstrip airstrip.com
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Released last year, Airstrip allows patients and doctors to stay up-to-date with each other’s statuses in real-time. Information taken from the patient’s Apple Watch®, such as heart rate, blood pressure, pill schedule, etc., can be delivered immediately to the patient’s health care team, allowing doctors to have constant and continuous monitoring abilities of patients healthcare data. The app complies with the Health Insurance Portability and Accountability Act (HIPAA), a federal law that strictly protects a patient’s private health information.
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Medtronic/ IBM Watson medtronic.com
“In the Medtronic app being developed, we plan to have Watson synthesize information from Medtronic insulin pumps and continuous glucose monitoring devices— detailed information like the rate of insulin delivered, the constantly fluctuating glucose level and carbohydrate intake information,’’ says Pamela Reese, a spokesperson for Medtronic. “The app may also integrate information sources like wearable activity trackers, digital scales, geo-location data, calendar details and even the weather, to develop more valuable and personalized insights.” The app was unveiled earlier this year at the Computer Electronics Show (CES) in Las Vegas.
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PulsePoint Respond pulsepoint.org/pulsepoint-respond
Released in July 2015, PulsePoint Respond alerts everyday citizens to provide life-saving assistance to victims of Sudden Cardiac Arrest. The app allows users to send out cardiac arrest emergency alerts through the app to dispatch any CPR-trained citizens to the area of the emergency.
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9 Reasons
TO C O N S I D E R J O I N I N G A
SITE NETWORK As competition for studies among research sites increases, site networks are playing a larger role in the clinical trial industry. See why a site network would benefit your research site. Article by Douglas Cavers
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WHY SHOULD RESEARCH SITES JOIN A SITE NETWORK?
1 A network offers sites an expanded Business DEVELOPMENT TEAM Network BD teams are focused on funneling competitive studies to sites, whereas most sites must divide their time between conducting awarded trials and gathering new leads. By outsourcing BD efforts, sites access more opportunities without the cost of hiring dedicated staff.
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A NETWORK OFFERS Expanded Opportunities for Sites
A network provides competitive intelligence
Networks are constantly working to build relationships with a wide variety of study sponsors, including smaller and lesser known biotechs. By joining a network, sites profit from these relationships, giving them access to a wider range of companies than feasible through individual outreach.
Because they communicate daily with hundreds of industry leaders, networks can alert sites to upcoming study opportunities before they are widely publicized. This information is invaluable; submitting early in the feasibility process is one of the best ways for sites to get awarded more competitive studies.
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A network centralizes business development efforts
A network is ideal for new therapeutic areas
Sites benefit from a network’s reputation
Networks increase efficiency by recommending sites for study leads through a single point of contact. Sponsors love this, because it makes their job easier. Sites love it because it lands them more studies with less effort.
Even well established sites have difficulty winning studies in new indications, often because it requires building connections with new and unfamiliar companies. By casting a wider net across the clinical trials industry, networks are able to immediately provide study leads in almost any therapeutic area.
Networks become successful because sponsors and CROs view them as efficient and reliable. Therefore, sites that submit through a well-known network often enjoy a competitive advantage over sites that submit to sponsors directly.
7 A network increaseS sites’ visibility Networks help create bridges to key sponsors and CROs through constant promotion of their sites’ capabilities and experience. Sites in networks can use this increased visibility across the industry to create new partnerships.
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Consulting with a network can improve site operations
A network HELPS SITES MEET THEIR FEASIBILITY DEADLINES
Many site networks offer standardized operating procedures that sites can implement to enhance their efficiency. Sites can develop new strategies for growth through consultations with a network, benefiting from the network’s wider view of industry trends and practices.
Never miss a study opportunity because it got lost in your inbox! Most networks track study leads throughout the feasibility process to site selection.
Want more information about site networks? ClinEdge Network has been successfully representing sites across North America for over five years. Contact : Nick@Clin-Edge.com to learn more.
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Travel is Part of the Patient Experience We’ve seen it time and again; patients are more likely to follow through with a study when they have reliable transportation to and from their study visits. That’s why ClinEdge Engage offers travel coordination services for all modes of transportation, as well as reimbursement processes for out-of-pocket expenses incurred during a trip. Article by Nicole Stratton
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PATIENT TRAVEL & YOUR TRIAL We all know that patient recruitment in a clinical trial is crucial for the trial to move forward successfully. There are many barriers that threaten patient retention, one of the largest being patient transportation. Across all indications, travel to and from a study site can be burdensome to the patient, whether it be the reliability of transportation, the expense, or any physical obstacles the patient faces. Many patients may not even
patients and caregivers. We aim to remove
world. We have experience throughout
the burden off of study sites, patients,
North America and Europe, and offer 24/7
and caregivers by offering a streamlined
support in all timezones and languages.
process for travel coordination, as well as expense reimbursement for visits during
Whenever we craft a patient travel plan,
the clinical trial.
we build it around two main objectives: providing the most convenient travel
Our travel team understands the clinical
experience possible to your patients and
trial industry, providing reliable support
reducing burden on study site staff. We
on both the patient and site level.
let you focus on what matters most–the
METHODS OF TRANSPORTATION
patients you care for.
consider the clinical trial opportunity if
ClinEdge Engage travel services
extensive travel is involved, and those that
coordinate all methods of transportation,
do may eventually discontinue the study
including airfare, hotel stays, and
Patients expect the booking process to be
as the burden of travel is oftentimes too
additional ground transportation. We also
seamless and hassle-free. Our travel team
much.
offer reimbursements for personal vehicle
centralizes all bookings through a single
mileage and out-of-pocket expenses
point of contact. Our process is simple:
during the study visit, such as meals.
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ClinEdge Engage’s travel program has identified these barriers to patient
Site identifies a patient who is eligible for travel assistance.
recruitment and retention and has
With extensive knowledge of IRB’s and
developed a travel program that offers
regulations, ClinEdge Engage can help
hassle-free and reliable transportation for
coordinate travel in countries all over the
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CENTRALIZED BOOKING
2.
Site staff works with patient or caregiver to complete basic travel forms.
SAVE TIME
RETAIN PATIENTS 3.
ClinEdge receives these forms and contacts the patient or caregiver to book the travel itinerary that best fits their preferences.
REIMBURSEMENT Our reimbursement process is patientfriendly and IRB-compliant. In the U.S., patients receive reimbursements for travel-related expenses through a reloadable debit card, which is valid anywhere that accepts Visa. Outside the U.S., patients are reimbursed through direct deposit via our online portal.
INTERESTED IN CLINEDGE ENGAGE’S TRAVEL PROGRAM?
Visit our website for more information: www.Clin-Edge.com
MEET STUDY TIMELINE EXPECTATIONS
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CREATING CONNECTIONS
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agely Health is working to transform the way patients find trials. The Boston-based startup has been able to help oncology patients connect with doctors and trials across the country to receive the treatment they need. The group plans to expand their reach for years to come and have truly been able to make a difference in the lives of the patients they serve. CEO Jason Sager sat down with ClinEdge to speak more about the journey thus far and his plans for the future of research. Interview by Georgia Ward
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Q. What have you learned since starting Sagely Health? Although we have always been passionate about helping patients and formed Sagely Health on that basis, we have learned that patients are quite overwhelmed from the initial point of their diagnosis. They realize that the stakes are high, but in many cases, chemotherapy offers little with only months of benefit, while leaving patients feeling ill and weak. Oncologists have precious little time (beyond all the things they do already) to research a long-term strategy that goes beyond standard of care including available clinical trials. Neither patients nor doctors have the tools they need to help them navigate the existing system to find new diagnostics or therapies, despite the ~13,000 trials on-going in cancer today. As a result, patients feel lost and despondent, while their friends and families feel at a loss to participate constructively. We are fortunate to have found a great team of passionate professionals who have been able to significantly help patients in the last year, and we look forward to growing the business this year. We have been able to provide highly detailed reports directly to a number of patients and their medical team along with the necessary guidance to enable their understanding of the options and empowerment to discuss and action them. Patients and doctors alike have expressed appreciation for the value we add and the only thing we should have done differently is to have started sooner.
Q. What are some challenges your company faces and how do you address them? Four main challenges we face include: scalability, cost, effort, and information accuracy. First, there are so many cancer patients who need our help and each requires a great effort today in making a difference, it is difficult to fathom how we might be able to achieve our goal to support the
millions of patients who are fighting their cancer today. If we were to use oncologists alone, we calculated it would require a full-time hospital sized staff just to guide patients and the cost would be astronomical for all parties. In addition, we face third party reimbursement challenges because our current process advocates for the patient to obtain more from the system, which falls outside the interest of third party payers to support. There is a major challenge of an already existing study database throughout the United States. In addition to being difficult for patients to understand and lacking a good search tool, we have found that the data contained within it is outdated the majority of the time (depending upon the search). Perhaps because it is not recognized as a patient recruitment tool and instead only serves as a regulatory (FDA) requirement, the system is not being kept up-to-date. We believe the answer to these challenges is 1) an innovative technology platform that can address the needs for millions of patients, without significant cost, together with 2) a curated content database that is accurate and up to date and 3) experts who can bridge any communication gap and help patients to navigate the system to understand and action novel options. We are building this system today and already have several parts in place to serve an ever increasing number of patients. Once our system is being used regularly, it is our great hope that the effort in putting the ideas we find into action will become easier as well.
Q. How is the digital age affecting Sagely Health? Sagely Health is enabled by the digital age. With that said, there is no replacement for human interaction and our consultation service combines these two resources in a way that creates sustained value for our patient clients. With technology we are bringing our unique interactive online reports to patients and doctors all over the world today, including: China, Israel, U.K., Singapore, Australia, California, right from our office
Continued...
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Q. Where did the idea to integrate an entire team and process for each patient come from? After years of clinical practice in pediatric oncology, years in oncology drug development, and years of guiding cancer patients to find better options during my nights and weekends, I was able to obtain a unique prospective on cancer care. I could work on developing a single drug for pharma for 10+ years, only to see it fail in a clinical setting, and not help a single patient. That outcome was not good enough for me. I wanted to help many patients more significantly today. in Boston. Without the advent of the “digital age,� Sagely Health would simply not be possible.
Q. Where do you see the future of Sagely Health in the next 5 years? From the work we have done, we have been tremendously successful in increasing clinical trial enrollment from a 3-5% national average to 25%. However, this still leaves 75% of our patients without a viable clinical trial option, and few have the necessary resources to obtain novel options without a clinical study. Within the next 5 years, we would like to be using our information not only to help guide patients to currently available options, but also to direct the creation of options for patients such that every patient accesses a series of treatment options that are exciting and hopeful. By doing so, we not only feel that we will be serving the needs of patients, but also be accelerating cancer cures.
Q. Are there any competitors in your line of work? How does Sagely Health stand out among other similar companies? There are others who do small pieces of what Sagely Health does. These companies may provide consultation but lack a technology platform. Others may have a technological solution but lack the human interactions that make it understandable, and usable. Sagely Health stands out because our greatest priority is to help patients obtain the best outcome possible. We do this with individual patients today and are passionate about finding a way to do it with many more patients in the near future. By innovating the evaluation of both therapeutics and diagnostics, Sagely Health is creating a unique asset for the world.
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Through my experience of guiding patients, I realized patients needed someone to turn over every stone in finding options, do the due diligence to understand what data is available for those options, and then guide them towards a better understanding what each of those options mean for them. I used this knowledge to develop a proprietary process for Sagely Health, and operationalize each role in an organizational setting instead of doing it alone. My initial idea was for a team of experts to brainstorm and uncover treatment and diagnostic solutions. The team includes trained oncologists who assess and guide the patient, and are supported by curators who search, digest, and verify accuracy for the numerous sources of information we use. Together with the technology platform we are building with programmers, all contribute to an integrated approach.
Q. Is there anything you would change about the clinical research industry if given the opportunity? In addition to finding a series of exciting and hopeful options for every cancer patient, we would like to see those options provided without geographic restrictions so that every patient is able to access novel therapies without leaving their neighborhood. It is justifiably difficult to be dealing with cancer and yet necessitate travel for what is sometimes hundreds of miles just to access clinical trials. We also find it exceedingly difficult to enroll patients in trials because of lack of efficient communication. Often, the contact information is incorrect or the person named has left the institution. Increasing the ease of communication would go a long way in facilitating enrollment.
Q. Do you find clinical trials benefiting patients more/ are there more opportunities for patients to receive care through clinical trials?
What Do Patients Have to Say?
We feel that clinical trials represent the forefront of what
organization, Sagely Health, for anyone desiring the
medicine has to offer, supported by the wisdom of oncology
services of a professional oncology navigator. The cancer
experts who guide their creation and companies who work
treatment process is extremely involved and rapidly
together to try to improve the outcome of cancer. We find that
evolving. Dr. Sager has been highly responsive and has
with our patients, about 25% of the time there is a good clinical
remarkable contacts throughout the country who know
trial option within a reasonable distance from their home.
and respect him. He has admirably and compassionately
This is a great improvement from the national average of 3%
guided me and my family as I progressed through vari-
enrollment; however, this still leaves 75% of patients without
ous treatments, arranged professional appointments,
a viable option. Three out of 4 patients are far too many to be
and explored research and clinical trial options that are
excluding from the forefront of what the world’s top oncologists and scientists are creating.
personal to my condition. I am grateful that an MD rela-
Q. Could pharmaceutical companies make it easier/ play a larger role in helping to connect patients to clinical trials? Would you want them to? In order to do this, first and foremost, they would need to be unbiased and firmly standing in the patient’s corner. Unfortunately, when you have competition between companies, it creates a conflict of interest for the pharmaceutical companies to draw specific patients to their trial when that trial may not match the patient’s top priority. One way pharmaceutical companies could play a larger role in
“I wholeheartedly recommend Jason Sager MD and his
tive of mine initially put me in contact with Dr. Sager.”
– Jim, Pancreatic Cancer “Sagely Health has been our family’s trusted adviser in managing my wife’s fight against cancer. I can’t imagine where we would be without them.”
– Jeff, Gastric Cancer “Sagely Health’s incredibly hard work has succeeded in discovering exciting new therapies that were previously unknown by my doctors, but all of whom agreed were the best options for me.”
– Ross, Pancreatic Cancer
helping connect patients to clinical trials would be increasing
“Jason at Sagely Health has been available to us and
general awareness and support for those groups who take a
hands on. He gathered all my daughter’s medical records
systematic and unbiased approach to providing patients their
so he could contact experts and colleagues in breast
options. For example, our goal is not to fill one company’s
cancer. He has guided us in the direction to find adjuvant
trials, it is to fill them all, recognizing the differences in each trial
care after doing traditional surgery and chemotherapies
and making sure each has appropriate patients. By realizing
so my daughter can move on with her life and never look
that they can stop competing for the 3% of patients and begin
back again.”
collaborating on recruiting the 97% of patients, we will all be
– Maxine, Breast Cancer
able to benefit cancer patients, and would be much more effective than the typical approach taken today.
“Thank you for everything you did for my wife. You gave her some rays of hope when there appeared to be none.”
Another way pharmaceutical companies could make it easier
– Tom, husband of endometrial cancer patient
to connect patients to clinical trials is to write the protocol and inclusion/exclusion criteria in a less-restrictive way, and in a standard format. Too often do we find a perfect clinical trial for a patient, only to find the criteria have not been detailed sufficiently or are outdated and our patient is excluded.
Learn More about Sagely Health : www.SagelyHealth.com Or Call: (844) 724-3591
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SOCIAL MEDIA Your Clinical Research Marketing Tool
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At its core, patient recruitment is disseminating study
TARGETED ADVERTISING:
information to potential patients, allowing them to make
As social media has evolved, so has its advertising
an informed decision on participation. Recruitment can
capabilities. In particular, Facebook is one network that has
often be one of the most challenging aspects of a clinical
proven to be a very effective paid advertising medium when
research study, especially as more and more study protocols
it comes to patient recruitment. Facebook allows you to
include tougher inclusion/exclusion criteria. While many
create attractive advertisements that appear just like any
research sites still rely on expensive traditional advertising
other post in a user’s newsfeed. The average Facebook user
methods such as TV and print ads, social media has proven
clicks on 12 advertisements per month. Most advertisements
to be a fast-growing, inexpensive, and successful patient
that ClinEdge runs on Facebook cost anywhere from only
recruitment channel.
$0.01 per click to $1.00 per click. This easily makes Facebook frequently rank as one of the most cost-effective patient
One of the biggest benefits to leveraging social media as a
recruitment mediums.
recruitment tool is that it allows you to connect with people in a way that’s comfortable to them. According to Facebook,
Facebook advertising is also much less risky than other
there are presently 150 million to 200 million monthly
methods, if implemented correctly. For example, rather than
active users in the United States, ages 18+. These are people
spending $7,000 for a two week radio run that is served to
regularly engaging with others and things that interest them
a general population, Facebook allows you to highly target
across the platform. Two of the top ways you can leverage
your placements. You can target based on a very specific
social media to break down the barrier between patients and
location radius, such as only serving the ad to people
research studies are through brand awareness and targeted
located 10 miles around the research site. You can also
advertising.
target based on demographics such as age and gender, and even a user’s particular interests, such as only serving ads
BRAND AWARENESS:
to those who have “liked” the American Heart Association’s
Leading companies in the clinical research industry have
page.
already tapped into social media in order to increase study awareness and enrollment with a comprehensive digital
Social media advertising continues to evolve and become
marketing strategy. Digital platforms such as social media
more advanced, so it’s important to stay up on its
channels can be used as a key marketing tool to increase
capabilities and how you can utilize it to effectively connect
awareness of clinical research sites and their recruiting
with patients.
studies. ClinEdge has seen enormous success implementing tactics Websites and mobile applications, such as Facebook, Twitter,
for both brand awareness and targeted advertising. If you
LinkedIn, Instagram and Snapchat, enable companies to
would like assistance in levering social media to enhance
professionally promote their brand while simultaneously
your site’s brand awareness or patient recruitment
creating an open forum for potential patients to engage with
strategies, please contact us.
site staff. This way, social media has the ability to bridge the gap between pharmaceutical companies, research sites, and the general public in a way that facilitates the feelings of inclusion and trust. It’s important, though, to have a comprehensive social media marketing strategy to implement. Simply setting up social media pages and posting a few sporadic updates will never
Want to learn more about social media strategies? Contact US today! www.clin-edge.com | 857-496-0054
result in a high level of engagement with followers. Social media is a long-term investment that can really pay off over time and bolster recruitment efforts both for regular clinic patients as well as study candidates.
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www.Clin-Edge.com 137A Lewis Wharf, Boston, MA 02110