Clinical Research Coordinators: The Glue that Binds a Clinical Research Program

Clinical research coordinators are an incredibly important part of the clinical research process. Their role has continued to evolve in recent years, as clinical trials have continued to grow in complexity. This evolved role has led to better data collection, greater protocol compliance, and overall improved subject safety. Because of their crucial role, many have come to recognize clinical research coordinators as the glue that binds clinical research programs.

Until the early 80s, the role of Principle Investigator (PI) routinely included the roles of the researcher, main patient-care provider, and data manager all at once. As clinical trials became more complex, PIs began to delegate some of these duties to others, which resulted in the need for senior nurses to have an expanded knowledge of the research process. These senior nurses soon redefined their role as “research coordinators”, and began taking on many of the very important clinical research processes.

One of the main parts of the clinical trial process that clinical research coordinators are involved in is the study start-up process. Clinical research coordinators must review the study protocol in detail to extract important elements of clinical and logistical feasibility, and then communicate with the PI to discuss any potential barriers in patient recruitment, study logistics, or data collection.

Clinical research coordinators are crucial in maintaining institutional compliance, and they must review coverage analysis properly to ensure all tests and procedures are properly documented. For some studies, research coordinators must also communicate with the PI to ascertain which tests and procedures are routine care, and which are research-related. After trial milestones are achieved, the research coordinator is responsible for communicating what tests and procedures were performed to ensure billing can be properly adjudicated. Clinical research coordinators are also tasked with guaranteeing that data from studies is properly delivered to the sponsor.

Clinical research coordinators are vital to the patient recruitment and enrollment process, and serve as the link between the patients, the patients care team, and the PI. Research coordinators often pre-screen patients, and they help drive the enrollment process by ensuring that proper informed consent is obtained, all screening activities are achieved, and that all inclusion/exclusion criteria are met before a subject is randomized into a trial. Clinical research coordinators are also uniquely positioned to protect patients, and typically have good relationships with their patients. Clinical research coordinators make sure that patient health information (PHI) is kept secure, and are often exposed to vital patient information. The research coordinator is also in communication with the sponsor teams and study monitors, and receives valuable correspondence on items such as patient safety reports and protocol amendments, which gives them the ability to react quickly to protect the patients.

Clinical research coordinators are a vital part of the clinical research process, and they ensure that studies run smoothly, compliantly, and efficiently. Research coordinators serve as a liaison between the research team, the PI, the patients and the sponsor. They help protect patient health and safety, while also instilling trust and confidence in their patients. Research coordinators serve as the gatekeeper of data, and they have the rigid discipline to follow protocols to ensure that the clinical research process goes smoothly.

Five Reasons Why Every Clinical Research Site Should Consider Joining a Site Network

For many research sites, navigating the clinical trial landscape can be very intimidating. Gaining credibility, making meaningful connections with sponsors and CROs, and finding new study opportunities can be difficult and time-consuming, and doing these things while also conducting high-quality research can be even more challenging. To combat these challenges, many research sites turn to clinical research site networks. Site networks offer many benefits to research sites, but here are five main reasons why every clinical research site should consider joining a site network:

1.)    Access to New Clinical Trial Opportunities

Finding and completing studies is the backbone of any clinical research site, but identifying and obtaining studies that are right for your site can be very challenging. The clinical trial landscape is extremely competitive, so standing out to sponsors and CROs is crucial in being selected for the studies you want. Joining a site network is a great way for research sites to gain credibility, and sponsors and CROs often look to site networks first to find sites to conduct their trials. Site networks secure hundreds of new study opportunities every year, so joining a site network is a great way for research sites to find new study opportunities.

2.)    Introductions to New Sponsors/CROs

A huge part securing study opportunities for your research site is having established relationships with sponsors and CROs, but establishing these relationships is easier said than done. Another benefit of joining a site network is that site networks already have good relationships with many different sponsors and CROs, which takes the pressure off research sites to form these relationships. By taking the pressure of forming relationships with sponsors and CROs off of your research site, you can focus on what is really important - your patients and your research.

3.)    Single Point of Contact

Effective communication between research sites and sponsors and CROs is a crucial part of the clinical research process, but this process isn’t always easy. Site networks can offer the benefit of a single point of contact between research sites and the sponsor/CROs, which makes the communication process much simpler for both parties. Effective communications between research sites and sponsors/CROs can lead to much more effective study start-up times, which is something that every research site should aim for.

4.)    Streamlined and Accelerated Study Start-Up Process

Study start-up times are a challenge for sponsors, CROs, and sites alike, but joining a site network can greatly accelerate and streamline this process. Site networks can accelerate the study-start up process in many different ways, including assisting with submission processes, negotiating contracts with sponsors and CROs, and helping with patient recruitment. By improving study start-up times, research sites can build their reputation while still maintaining focus on their patients and research.

5.)    Site Networks Centralize Administrative Functions

For many research sites, administrative functions can sometimes be pushed to the back burner. Many research sites would rather focus on their patients and research, which makes finding time for administrative tasks difficult. Research sites may not have allocated staff to focus on exclusively on administrative functions, but another great benefit of site networks is that they offer many services to help centralize these administrative functions. Administrative functions that site networks can help centralize include account receivables and financial services, business development, and contract and budget negotiations. Site networks can help centralize these administrative functions all while allowing the research site to focus on what is most important to them.


No two research sites are the same, and finding what works for one research site may be different for another. Site networks provide anything from a-la-carte services to full-scope staffing and financial services, which gives research sites a lot of flexibility. Site networks are a great way for research sites to find what processes work for them, all while streamlining their study start-up processes, building meaningful relationships with sponsors and CROs, and most importantly, letting research sites focus on what they do best: care for patients.

Content Marketing 101

What is Content Marketing?

The Content Marketing Institute defines it as, “A marketing technique of creating and distributing valuable, relevant, and consistent content to attract and acquire a clearly defined audience-with the objective of driving profitable customer action.” Essentially, content marketing is the process of developing content and distributing it to engage potential customers. Unlike more direct sales and marketing tactics, content marketing allows you to more subtly deliver something of value to your target audience. Content can be many things. It can be a blog post, an infographic, a video, a whitepaper, or a podcast, just to name a few.

How do you ensure you’re creating valuable content?

The answer will differ for everyone, and it may take some time to figure out. Think about what your customers would find valuable, and what’s relevant to your business. Another thing to consider is the idea of recycling content. Different platforms reach different audiences, so making content available in more than one style and location will only increase visibility.

Once you start creating content, look at what content is best received. Page views, click-throughs, and other metrics will be helpful to determine this. If you’re new to tracking metrics, many platforms like Facebook and LinkedIn already have built-in tools that show you how well your content is received among viewers. Other free tools like Google Analytics can be installed to give you a better picture of these metrics as well.

How can I share my content?

There are several ways you can share content. One easy way to do this is through social media. Whether it’s a blog post, an infographic, or a YouTube video, share a link to your content on all of your social media platforms. Another easy way to publicize your content is on your website, or for a more traditional way of sharing content, try sending paper mail such as a flyer or a post-card.

If you’re looking for a more direct way to promote your content, you may want to send a marketing email. If you don’t already utilize email marketing, there are many tools you can use such as Constant Contact and Mailchimp that allow you to create professional looking marketing emails to send to a subscriber database.

When considering platforms, think about your audience. Their demographics will influence the platforms you should use. For example, if you’re targeting an older population, you may want to stay away from social media, and focus on more traditional forms of outreach like print. On the other hand, if you’re targeting a younger audience, consider a more digital approach. Above all, there are many ways to share your content. Keep in mind that there is no ‘best’ platform to use, and it’s certainly beneficial to try more than one.

Why content marketing?

There are multiple reasons to consider using content marking. One of the most important reasons is to build brand recognition. You want to generate awareness of your products or services to a wide audience, and creating valuable content that people want can help you build that recognition. Greater brand recognition goes a long way. It can lead to increased website traffic, more followers on social media, and ultimately more customers.

Another benefit of content marketing is that it can help you build credibility, particularly if your content is educational and relates to your business’s area of expertise. This is an especially relevant benefit for the healthcare industry, as expertise and experience are huge factors in attracting new patients.

Content marketing is also beneficial in that it can be low cost. Many forms of content, such as blogging, simply require an hour or two of your time to develop.

Lastly, content marketing works because it’s subtle. In today’s environment, consumers are constantly bombarded by marketing and sales messages. These tactics often end up doing more harm than good, as they’re seen as overly pushy.

How do you get started?

Once you’re ready to get started, there are a few things to consider:

Your first decision is what type of content you’re interested in sharing. Are you going to create some infographics and videos for your website? Maybe you’ll send out a post card with healthy recipes or start a blog utilizing industry related news. Next, you’ll have to think about how to get your content out there. As I mentioned, consider your target market’s demographics when choosing a strategy. Before you get started, make sure to have a plan for consistency. Whether you share content once a month or once a week, make sure you’re consistent.

Once you’ve thought about platforms, you’ll want to decide whether to utilize in-house staff or outsource the service. There are many firms and agencies that offer content marketing services, one of which is PatientWise, PharmaSeek’s sister company, who has experience in the clinical research and healthcare space. Outsourcing may be a good place to start if you lack time and expertise. However, if you’re looking to do it yourself, there are many other resources that can help: for example, websites like Forbes and Hubspot offer hundreds of free articles and guides to get you started.


To conclude, developing a content marketing strategy is a great way to increase brand recognition and build credibility for your business. If you are interested in more information on content marketing, or are ready to get started, send us an email at!

May News Roundup: What’s New in Research?

Stem Cells Edited to Fight Arthritis – Read More >

Researchers at the Washington University School of Medicine and Shriners Hospitals for Children have rewired stem cells from mice in an effort to reduce inflammation caused by arthritis and other conditions. These stem cells are developed into cartilage cells that produce a biologic anti-inflammatory drug that may be able to replace arthritic cartilage, protecting joints and other tissues from further damage.

Research Moves Closer to Unraveling Mystery Cause of Multiple Sclerosis – Read More >

An international team of researchers has discovered a defect in brain cells that may cause Multiple Sclerosis (MS). The study, which was published in the Journal of Neuroinflammation, has addressed a largely unknown aspect of MS. This discovery may also pave the way for research to investigate new treatments for those with MS, a population of about 2.5 million individuals worldwide.

AHA Brings Latest Research On Heart Disease Out of the Lab and Into Older American’s Homes – Read More >

The American Heart Association is working with the home care provider Honor to take heart disease and stroke research into the homes of patients. Home health care professionals will be provided with science-based information so that they can better treat their patients. This initiative is one example of the growing movement to broaden the impact of clinical trials.

Novel Compound Blocks Replication of Zika and Other Viruses – Read More >

Researchers may be one step closer to controlling outbreaks of Zika and other viruses such as Chikungunya and Dengue. The study, which was published in mBio, reveals a novel compound that triggers cells’ innate antiviral system. Cells of vertebrates have developed pathways that create an internal defense, inhibiting infections by preventing replication of pathogens.

New Blood Test Offers Potential for Faster, Targeted Treatment of NSCLC – Read More >

Patients who are suspected to have NSCLC typically receive an invasive tissue biopsy in order to diagnose their condition. A new blood test reported in The Journal of Molecular Diagnostics may simplify this process by quickly identifying gene mutations associated with NSCLC. Additionally, community-based practices that don’t have access to hospitals with diagnosis/treatment facilities will be able to test their patients for NSCLC.

Looking for more research news? Check out these resources:

CenterWatch News Online

World Pharma News

Applied Clinical Trials

3 Tips for Site Selection

Site selection is a complex process composed of multiple factors on which research sites are evaluated. It may seem as if your success is solely in the hands of sponsors and CROs, but there are several things you can do to help your site get selected on more studies. Here are three tips from the site selection and business development team at PharmaSeek:

Tip 1: Get started by Building Meaningful Relationships

If you want to start conducting more clinical trials, the first step is to network and build meaningful relationships with other sites and sponsors/CROs. If you don’t know where to begin, start by leveraging existing relationships you have with other sites that conduct clinical trials to get familiar with the study startup process. Though it’s a simple step, networking is a conscious effort to ensure that your site’s name is getting out there. If you’re sending research staff to attend conferences, make sure to attend sessions and make use of the allotted networking time to track down key contacts. Once you gain these contacts, remember to stay in touch and build relationships.

Tip 2: Treat the Questionnaire Like a Job Interview

Instead of treating the feasibility survey as another document to be filled out, try to view it as an opportunity to sell your site and stand out from the crowd. It’s easy to just check the necessary boxes and answer the bare minimum, but take advantage of those open-ended questions and comment sections to show why your site is a good fit for a study. Does your PI have an extensive research background? Do you have a lot of patients with the listed indication? If you’re trying to break into a new therapeutic area, this is the place to provide context to the sponsor by including an explanation of why the sponsor should take a chance on your site. Similar to a resume, you need to highlight the selling points of your research site.

An easy way to streamline this process is to have a standard procedure in place to ensure a study is a good fit. Have your enrollment metrics of past studies on hand and attach site promotional materials, like brochures, a website link, or a list of studies conducted. By having all of this information at an arm’s reach, it’ll ensure you don’t miss anything when you begin filling out the survey.

Tip 3: Anticipate Red flags

If possible, think of any weaknesses your site might have in relation to the study you’re applying for and address them before the sponsor can. It gives you the chance to craft your answers to show you acknowledge a certain pitfall and what you have in place to address the issue.

Here are some quick examples:

“How many Type 2 diabetes patients do you treat per month?”

  • Weak Answer: “0”
  • Stronger Answer: “We are a dedicated research facility and only see subjects for clinical trials. We have 1,000 Type 2 diabetics in our research database who want to participate in trials, and approximately 25% of them would meet the I/E criteria.”

“How many studies has your PI conducted?”

  • Weak Answer: “0”
  • Stronger Answer: “None, but he has received GCP training and has been a Sub‐I on five studies. Our site has conducted over 100 trials in the last 10 years, including 12 for this indication. Our study coordinator has 15 years of research experience.”

A good rule of thumb is to put yourself in the sponsor’s shoes and ask, would this answer cause concern? It’s always best to provide an explanation for a shortcoming. Whether the protocol was especially difficult or the previous study simply closed early, you want to be transparent with the sponsor. Even if there were no external causes and your site just didn’t perform well on a study, provide the sponsor with any lessons learned and how you will avoid a repeat performance.


Once you’ve started conducting a study, remember to make use of this momentum! Focus on business development and maintain relationships with key personnel. If you have a successful trial, piggyback off the success and explore strategic alliances. The landscape of clinical trials is always evolving and it’s important to maintain the relationships you form along the way.

February News Roundup: What's New in Research?

World’s Smallest Pacemaker Revealed – Read More >

The Micra Transcatheter Pacing System (TPS), a new pacemaker the size of a nickel, can now be implanted in patients with bradycardia to help pump enough blood through the body during physical activity. The tiny device is just 1/10th the size of a traditional pacemaker, and it is currently the only leadless pacemaker approved for use in the United States. The TPS is also unique in that it doesn’t require cardiac wires or a surgical pocket under the skin to deliver a pacing therapy.

Subject Injury Language: What You Need to Know

One of the negative aspects of clinical trials is the possibility that a patient will suffer an injury or illness as a result of their study participation. As such, one of the most important pieces of a contract is the subject injury language. ‘Subject Injury’ is defined as an injury, illness, adverse event/reaction, or death caused by a study subject’s involvement in a clinical research study. Prior to the study, the research site and the study sponsor should come to an agreement on what exactly constitutes a Subject Injury, and who pays in the event of a Subject Injury.

Print Marketing: A Viable Option for Patient Recruitment

As many markers know, the sustainability of print advertisements has been thoroughly questioned in today’s digital age. In June of 2012, Forbes Magazine published an article about this very issue—taking a stance that surprised many at the time. Forbes stated, “While many businesses have completely migrated their advertising efforts to the web because of its cost effectiveness, exposure potential and convenience, print still maintains its stance as a powerful and necessary component of an ad campaign.” 

Benefits of a Clinical Trial Management System

A Clinical Trial Management System (CTMS) is a computer software system that manages data within a clinical trial. The system centralizes the administrative components of each study, including billing, reporting and tracking.  Many research sites, institutions, sponsors, and CROs use these systems to monitor clinical trials. Below are 3 key benefits of implementing a CTMS.  

Is Branding a Research Site Necessary?

Branding is extremely important when trying to establish a credible business. Whatever it is that you are selling - food, tools, beauty products, pet supplies, a type of service, etc. - your business needs a brand. Believe it or not, in addition to companies like Coca-Cola, McDonald’s, Starbucks, and Target, clinical research sites and health institutions must also have a solid brand behind them. Some people believe that a concrete brand is not necessary for the healthcare industry because the demand for healthcare will always be prevalent. The fact that the demand will always be around is true, but there is still competition in the healthcare industry, and standing out from the crowd is crucial to attract new patients. 

Working with PharmaSeek: Sponsors and CROs

Finding research sites that are capable and willing to conduct your clinical trials can be a burdensome task. Since 1995, Pharmaseek has partnered with both sponsors and CROs to identify clinical research sites for clinical trials in virtually every therapeutic area. What started as a group of twelve research sites has grown into a network of approximately 250 investigative research sites, the largest network of its kind. Research facilities in the PharmaSeek network range from small practices to large academic institutions.

HIPAA: Reflecting on the Past and Preparing for the Future

When the Health Insurance Portability and Accountability Act (HIPAA) went into effect over 10 years ago, it was met with great apprehension and concern from those in the healthcare industry. Today, it is one of the most important legal and ethical guidelines in the industry. How has HIPAA evolved since its inception? Let’s step back to examine a few key points in its development.

Are small, independent research sites going the way of the dinosaur?

Much has been written about the changing clinical research landscape, and more importantly, the implications these changes are having on small, independent research sites. The first major change was the implementation of preferred site programs by many larger contract research organizations (CROs). The second, and more recent development, is the actual acquisition of research sites and site networks by CROs. Separate of both of these trends, is the premise that “big data” will give larger health systems a competitive advantage, allowing them to reestablish their dominance in Phase II and III research. Each of these themes are explored in greater detail below.