February 17, 2023 Clinasyst News

5 Reasons Your Site Needs a CTMS

Clinical trials are an integral part of the pharmaceutical industry, and they require meticulous organization and management. As clinical trials are becoming more complex, time-consuming, and expensive, it has become critical to manage them efficiently. That’s where Clinical Trial Management Software (CTMS) comes into the picture. CTMS is a centralized platform that enables efficient management of clinical trial data, processes, and workflows. In this article, we’ll explore the benefits of using CTMS for a research office.

Improved Efficiency:

One of the significant advantages of using CTMS is the improvement in efficiency. CTMS enables research offices to automate manual processes, reduce paperwork, and optimize workflows. With CTMS, study teams can easily manage the trial lifecycle, from study planning and start-up to execution and closeout. CTMS can help streamline processes such as subject recruitment, informed consent, site activation, and site monitoring. By automating these processes, CTMS reduces the risk of errors and saves time, enabling research offices to focus on more critical tasks.

Improved Data Management:

Clinical trials generate a vast amount of data, which can be challenging to manage. CTMS helps manage clinical trial data effectively by providing a centralized platform to store and track data. CTMS can also generate customized reports, providing insights into trial performance, progress, and results.

Increased Compliance:

Clinical trials are subject to strict regulatory requirements, and non-compliance can result in severe consequences. CTMS can help ensure compliance with regulations by providing standardized processes and workflows. CTMS can also track and manage documentation, facilitating audit readiness. By ensuring compliance, CTMS reduces the risk of regulatory violations and associated penalties.

Improved Communication:

Clinical trials require collaboration among various stakeholders, including investigators, study coordinators, regulatory, business development and recruitment departments, and sponsors. CTMS provides a centralized platform for communication and collaboration, enabling stakeholders to share information, track progress, and resolve issues. CTMS can also provide alerts and notifications, ensuring that stakeholders are aware of critical events and timelines.

Cost Reduction:

Clinical trials can be expensive, and managing them efficiently can reduce costs. CTMS can help reduce costs by optimizing workflows, reducing errors, capturing SAEs and minimizing duplication of effort. By streamlining processes, CTMS can also reduce the time required to conduct trials, enabling research offices to complete studies faster and more cost-effectively.

It’s important to note that there are several CTMS solutions available in the market, and choosing the right one can make a significant difference in the success of a research site. ClinasystNG is a CTMS designed specifically by clinical research sites, making it an excellent choice for research offices looking to optimize their trial management processes.

ClinasystNG is a comprehensive CTMS solution that offers several features that can help research offices work more efficiently and increase revenue. For example, the platform can automate many of the manual processes involved in clinical trial management, reducing the time and effort required to complete these tasks. This not only saves time but also reduces the risk of errors, ensuring that data is accurate and consistent.

Furthermore, ClinasystNG offers a wide range of reporting and analytics tools that enable research offices to track the progress of their trials and identify areas for improvement. This insight can help teams optimize their workflows and make data-driven decisions that can increase revenue for their organization.

In summary, ClinasystNG is an excellent CTMS solution that offers a range of benefits to research offices. By enabling staff to work more efficiently and increasing revenue for the organization, ClinasystNG can help research offices successfully manage their clinical trials and bring new treatments to market faster.


January 5, 2023 Clinasyst News

Ahoy ye mateys! Have you ever wondered which enemy was the most dangerous to sailors during the 1700’s? James Lind, a Royal Navy surgeon, described a foe which “proved a more destructive enemy, and cut off more valuable lives, than the united efforts of the French and Spanish arms.” In order to conquer this threat, Lind employed a brand new weapon. This weapon was previously unknown to science, and has now been used to defeat countless foes. The enemy was scurvy, and the weapon was a clinical trial.

May 20, 2022  marks the 275th anniversary of that first clinical trial. Scurvy could lead to muscle pain, gum disease, fatigue, jaundice, and death. Remedies at the time varied widely and only anecdotal, word-of-mouth evidence for them was available. Every sailor who was afflicted with scurvy sought a cure, but the overall disease was caught in the doldrums without a solution for 150 years. Lind had bigger ambitions. His big insight wasn’t trying to treat just a few individuals for scurvy, but instead trying to solve the problem of scurvy on the scale of public health. Though he only had 12 participants in that first trial, how Lind compared different remedies showed his big-picture thinking. He sought not to give relief to just those 12 patients, but to quantify and share his results to cure the whole of the Royal Navy.

In this effort Lind laid the groundwork of the modern clinical research study. He started with a set of 12 patients with conditions “as similar as I could have them.” He controlled extraneous variables, giving all patients the same diet during the study and keeping them on the same boat. He split them into 6 random conditions:

  • A quart of cider per day
  • Elixir vitriol (sulfuric acid and alcohol), 3x daily 
  • 2 spoonfuls of vinegar, 3x daily
  • ½ pint of seawater per day
  • 2 oranges and 1 lemon per day
  • Bigness of nutmeg (a medicinal paste made of herbs and spices)

The results were clear; citrus gave quick and significant relief.  Importantly, Lind didn’t leave his findings high and dry. He recorded and reported what he saw. Probably the most important aspect of Lind’s clinical trial was that he looked at the results in an unbiased way. He wrote extensively on the need to remove personal and societal bias:

“it is no easy matter to root out old prejudices, or to overturn opinions which have acquired an establishment of time, custom, and great authorities; it became therefore requisite for this purpose, to exhibit a full and impartial view of what has hitherto been published on scurvy.”

Today the same core ideas guide clinical trials, but there are many more safeguards for participants. A good clinical trial today is grounded in science, provides benefits to patients that should outweigh any risks, and treats patients with respect. Critically, clinical trials have informed consent; all participants join voluntarily and must have full knowledge of any risks before signing up. Trials also have oversight from Institutional Review Boards and have medical staff on site to help with any adverse reactions. Following Lind’s example, clinical trials also target specific conditions, have randomized patients, control conditions (as much as possible), and dutifully record and report their findings.

Though his aim was to blow scurvy out of the water, Lind ended up making waves in how scientists solve medical problems in general. His quantitative, balanced approach gave the world a system to tackle medical problems. On this International Clinical Trials Day we can help keep up the bounty of Lind’s legacy by volunteering as a clinical research trial participant and send some disease to Davy Jones’ Locker!

Written by Benton Lowey-Ball, BS Behavioral Neuroscience

Lind, J. (1753). A treatise of the scurvy: in three parts, containing an inquiry into the nature, causes, and cure, of that disease, together with a critical and chronological view of what has been published on the subject. Bulletin of the World Health Organization: the International Journal of Public Health 2004; 82 (10): 793-796.From


July 29, 2022 Clinasyst News

Earlier this year, a bipartisan bill was introduced in the US congress to increase diversity in clinical research trials. The DEPICT act, as it’s called, has many major changes to how clinical trials would be conducted. These changes would affect sponsors, the government, and clinical research sites. Sponsors are the companies which develop new drugs and devices in clinical trials.

The bill would require new demographic analyses for drug and device trials by sponsors. Demographic data includes age, sex, race, and ethnicity. Sponsors would investigate the rates of a disease among demographic groups before starting a trial. They would then devise a diversity action plan. This ensures the clinical trial includes a representative sample of the affected population. Let’s say a drug targeted lung cancer, for example. The sponsor would have to find out who has increased chances of getting lung cancer. If they found that Black Americans were at higher risk, they would make a plan to ensure this group was included in any research trials. Plans could include community outreach, specific site selection, and diversity training.

A key aspect of the bill is discovering how to best reach diverse communities. Research sponsors would need to submit annual reports. These would outline how successful their studies were at reaching the demographic goals. If they failed to meet goals, they would give possible reasons they did not. The Food and Drug Administration (FDA) would compile and analyze the reports. The FDA would issue public reports on diversity and enrollment targets. They would also publish justifications for failure to meet targets and recommendations to solve this. Additionally, the National Institute of Health (NIH) would provide outreach. For sponsors, they would issue best practices for increasing diversity. They would engage with minorities to bring awareness of clinical research trials. They would also help local organizations inform their community about research trials.

The final piece of the bill is increasing access. The bill would enhance clinical research infrastructure in underserved communities. The bill provides grants to expand clinical research facilities. These would be in rural areas, on Indian tribal lands, and in federally recognized underserved communities. The grants would help facilities conduct research trials in these areas.

Altogether, this bill addresses the shortcomings of clinical trials in diverse communities. It closes the gap between who suffers from medical conditions and who participates in clinical research trials. It helps find out which methods increase clinical trial diversity. It also helps expand access to clinical trials in underserved communities. There is still a long way to go before this bill makes it to the voting floor, but it’s a good step.

Written by: Benton Lowey-Ball, B.S. Behavioral Neuroscience

Source:  Text – H.R.6584 – 117th Congress (2021-2022): DEPICT Act. (2022, February 3).


July 14, 2022 Clinasyst News

5 Recommendations to Run a Successful Clinical Trial Business

  • Attention to detail:
      • Mistakes happen but how can we make the most of them? A critical part of any successful organization is catching and fixing the causes of mistakes before they impact the business. In clinical trials, mistakes can be severe, and must be caught and corrected swiftly and accurately. The best way to find errors is to meticulously comb through activities and inputs and look for discrepancies. Luckily, ClinasystNG can be that helpful team player! With detailed reports that track productivities, recruitment, adverse events, financials, randomizations, and more, your team can be sure they can catch errors and push your business to be the most successful it can be,
  • Qualified, motivated staff
      • A key aspect of any successful business is good quality staff, and that’s even more true in clinical trials. Good staff includes everyone from coordinators to nurses to recruitment and advertising. Keeping track of all these aspects and providing a concise way to communicate different ongoing trials, ads, and visits can be a challenge. ClinasystNG provides an all-in-one solution to facilitate communication and clarity for all staff, keeping everyone motivated and streamlining the process.
  • Provide patient-centered care
      • Successful businesses stand on their reputations, and the easiest way to build that is by living your ideals. A caring company with compassion for patients will find success through word of mouth, the strongest advertising tool there is. Caring about patients means having a clean facility and welcoming associates, but is much broader. Compassion for patients begins before recruitment; making sure patient information is stored securely. It continues by ensuring patients’ individual circumstances are considered, including transport and the value of their time.  Care continues after a study has concluded, with continuing care that provides additional touch points, and by continuing to keep patient data secure.
  • Match patients to their ideal study
      • The bottom line of any good business relies on matching a suitable product to a willing buyer. This is the same with clinical research. A good clinical trial  business doesn’t try to fill studies with anyone who passes the exclusion criteria, but instead tries to match willing, reliable, good quality patients to a study that matches their profile. A high quality patient that will complete a study and stick with your business is a gem, and ClinasystNG makes it easy to find. With powerful database management tools and a Research Ready scoring system for patients, ClinasystNG makes it easy to match patients to studies and keep track of who your best performers are.
  • Good Clinical Trial Management software
      • Efficiency can increase margins, but morale is critical to the basic function of a clinical trials business. One of the best ways to ensure both is through a high quality, easy to use clinical trial management system. A high quality system, like ClinasystNG, doesn’t just provide secure document storage, but also provides a framework for multiple clinical trial features, such as scheduling, financial tracking, patient management, and collaboration features. An easy to use system also incorporates predictive features to make repetitive tasks easy and quick.


June 21, 2021 Clinasyst News0

Shannon Trull | Vice President of Accounting & Finance at ENCORE Research Group

Shannon Trull is the Vice President of Accounting & Finance at ENCORE Research Group. ENCORE Research group is a large clinical trial organization with nine locations in Florida, and Shannon oversees the finances for all locations. 

“I couldn’t imagine going back to the days before ClinasystNG,” Shannon says as she recalls the many ways ClinasystNG has saved her facility time and money. Furthermore, one of her favorite features is SAE tracking. SAE (Serious Adverse Event) Tracking is a feature of  ClinasystNG where her team can easily track how many SAEs occur in a study while additionally collecting revenue from those SAEs.

Shannon says she loves how user friendly the platform is. For example, she says, “The coordinators can go into ClinasystNG, select when a SAE occurs, capture it and invoice it.” Shannon and her team are able to bring in more money for studies, because SAEs are captured in such a timely manner. Without the SAE tracking mechanism ClinasystNG has to offer, they would have to pull all SAEs at the end of a study. This leaves many to fall through the cracks without being invoiced. 

“There are so many more things we can capture now than we could before ClinasystNG.”

Additionally, there are other financial aspects of ClinasystNG that have also helped Shannon and her team. For instance, she says, “We are able to enter every single budget aspect into ClinasystNG. Even fees like administrative, pharmacy, re-consent, safety reports, moderating visits, advertising and more. We are able to put it all into ClinasystNG.”

ClinasystNG is also able to invoice more than just SAEs in a timely manner. It can also invoice all invoiceable procedures from pregnancy tests and unscheduled visits to lab draws.

“There are so many more things we can capture now than we could before ClinasystNG,” Shannon says. “Before, we may have just been able to do an end-of-study pool of data. Now everything is in a timely manner.” For example, if your site has a five year study that has just ended, there is no need to pull five years worth of data. Everything has been pulled the moment it happens. 

Lastly, Shannon says there is very little financially that she can’t pull from Clinasyst. “It has really turned our process around,” Shannon says. “Honestly, we couldn’t live without it.”

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