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.