Blogs

Cloud Concinnity® provides invaluable help for clinical trials administrators by centralizing all information securely in the cloud, automating critical compliance processes and pushing critical evaluations and alerts to decision makers.

In clinical trials, recruiting the right team is critical – from pre-selection through onboarding – as this human capital lays the foundation for trial progression. Clinical trials need people with intelligence who can adapt to the evolving world of clinical trials.

With a strong team in place, clinical trial timelines can be completed, data quality can be maintained, and costs can be mitigated.

The life sciences industry has undergone seismic shifts in the three years, with sweeping changes across research, development, and commercialization. Industry trends point to a world with fewer barriers, faster drug development, and more efficient communication.

Technology’s impact on how clinical trials are managed is profoundly changing how treatments move from research and development to market. This seismic change impacts everything from patient recruitment and retention to study design and execution, as well as affecting compliance and reporting results. Understanding how these trends shape the trial management process can help you successfully navigate this changing landscape.

As data privacy becomes increasingly important in the clinical trial space, data protection, in turn, becomes a higher priority for data safety and monitoring boards. To ensure the data you are storing is secure and private, clinical trials must implement strong data protection measures to keep their clinical trial data secure. Here are 7 data protection tips for data safety and monitoring boards.

As the clinical trial industry continues to expand in this post-COVID environment, Contract Research Organizations (CROs) need to hire more clinical trial managers to ensure the success of their studies. An experienced clinical trial manager can differentiate between a successful and unsuccessful trial. As such, they are integral to the success of a CRO’s operations. In this post, we’re sharing five ways that CROs can improve their clinical trial manager recruitment efforts.

One observation about clinical trials continues to ring true. Clinical trials are becoming more complex, and sponsors require more from their sites. Clinical trial managers must be aware of the latest trends in the clinical trial space to maximize performance and improve the likelihood of a successful clinical trial outcome. Below, we've compiled a list of the five clinical trial trends that you need to keep front of mind.

Software | & Software | |

As a clinical trial professional, you already know that protecting your trial data is of the utmost importance. A successful cyberattack can cause significant damage, delay trial completions, and introduce compliance, patience, and regulatory issues. To help your clinical trials stay cyber-safe, we're sharing eight cybersecurity tips for managing your clinical trials.

Our process automation capabilities are one of the most popular features of the Cloud Concinnity platform. With just a bit of planning, your team can automate tasks that used to take hours of manual time to complete. But, before you decide how and what processes and documentation you can automate, you analyze your current manual processes. Here are six tips to guide your analysis and documentation of your current state.

As the world increasingly relies on technology, it is no surprise that the clinical trial field is following suit. Virtual trials, also known as remote or decentralized clinical trials, involve using technology to collect data and monitor patient health remotely instead of in a traditional brick-and-mortar clinic setting. Successful virtual trials are built on a technology stack that meets the critical needs of virtual trials.

Over the past several years, decentralized trials have become more common (due to both the pandemic and improvements in support technologies). This trend isn’t going away anytime soon. However, while the landscape is continuing to shift in favor of DCT, a new survey from Florence Healthcare has found that many CROs don’t currently have the technology to accommodate this shift.

As the premier clinical trial oversight solution provider, we welcome feedback from our active user base and use this feedback to enhance and improve our cloud-based platform. We proudly announce improvements to the tasks and workflow functionality within our Cloud Concinnity Platform.

As you may be aware, hybrid and decentralized clinical trials allow researchers to successfully conclude a clinical trial while conducting it partially or primarily remotely. What you may not know is that a recent EY-Parthenon survey found that respondents estimate that 50% of clinical trials will be hybrid or decentralized by 2024. While hybrid or decentralized clinical trials bring with them a host of benefits, they do introduce new difficulties based on their differences from traditional clinical trials.

Clinical trials are complex and expensive endeavors that require researchers to track enormous amounts of data, manage multiple stakeholders/participants, and communicate efficiently - all while following protocols. And that's just single-location trials!

Key Opinion Leaders (KOLs) are critical to the success of any research study. The experience and credibility of your KOLs add legitimacy to a clinical trial while also helping to mitigate any potential risks. As such, attracting KOLs to your study, and keeping them engaged for future research studies, is an important element in driving long-term success. Working with our clients, we’ve identified that a driving factor in attracting and retaining KOLs is to improve the quality of life for trial KOLs.

When demand for new treatments increases, such as the immediate need for a vaccine for a novel coronavirus, it can pressure clinical trials to deliver fast, accurate, and positive results. These pressures have the potential to increase the risk of errors, mistakes, or the mismanagement of data – which is why we have clinical trial oversight committees. They ensure the accuracy and integrity of the study.

Clinical trials are essential to the success of new medical treatments and therapies. They help researchers study the effects of new treatments in a safe, controlled environment before these treatments are made available to the wider public.

However, running clinical trials can be expensive, time-consuming, and difficult. There are many different factors to manage, data to collect, and patients to monitor. This is why it's so important to develop standardized processes.

As a leading clinical trial oversight solution provider, our team of experienced subject matter experts and engineers consistently explores new features to build into the Cloud Concinnity® platform.

In speaking with our clients, we heard time and time again that they were concerned about their meeting efficiency. They felt that with their current tools, getting everyone’s schedules aligned to set a meeting was taking too much time.

Most traditional clinical trials operate under a model similar to: design the trial, conduct the trial, and then analyze the research. This has been the model for most medical research in the past and remains the predominant model. But times change.

A newer, more flexible trial structure is starting to make the rounds through the clinical trial space – adaptive design. Adaptive design offers many benefits to the researchers and the participants in a clinical trial.

In clinical studies, time is of the essence. Every moment counts, as any delay or misuse of time can directly affect when a potentially lifesaving drug can get to the market. Many factors can squander time during a study. Some are inevitably outside of your control, but others aren’t.

Constant in-person meetings, status checks, and message response delays can eat up valuable time in your clinical trial, distracting your team from focusing on the more significant issues.

Dose escalation studies have been used as a cornerstone in medical research to determine the most effective dose of a drug. They are usually part of early-stage, phase I clinical trials. But like so many things in our world, the COVID-19 pandemic changed how researchers approach dose escalation management. The immediate demand for a healthy, effective vaccine showcased the need for evolving best practices and spurred researchers to adopt new technologies.

Sponsors of clinical trials are under pressure to maintain patient safety and data quality, but the process is time-consuming and challenging to manage. This is where more intelligent clinical trial oversight software comes in handy. The correct clinical trial oversight software can automate many of the tasks associated with clinical trial oversight, improving sponsor trust. This blog post will discuss seven ways smarter clinical trial oversight software can enhance trust between sponsors and investigators.

Pediatric clinical trials are essential for developing new and innovative treatments for children. However, they can be more challenging to conduct compared to standard trials as they require more oversight. There are a few key things to keep in mind when planning and conducting a pediatric trial to guarantee a positive trial experience. This blog post will outline five tips for a successful pediatric trial.

As a leader in clinical trial oversight solutions, our team of dedicated
engineers and subject matter experts are constantly improving Cloud
Concinnity®, our integrated platform for centralizing, standardizing and
automating data, communications, processes & reporting. We’re excited to announce the following enhancements to the Cloud Concinnity Platform designed to to better serve the needs of our current and future customers.

Oversight boards and committees play a critical role in ensuring the safety
and efficacy of clinical trials. Given this responsibility, clinical trial
oversight boards must function at peak performance. The more efficient the
day-to-day operations of these boards, the more likely the study will be
successfully completed on time and under budget. In this blog post, we will
discuss four methods for ensuring your oversight boards can execute its
duties more efficiently.