Many clinical researchers struggle to meet enrollment targets, especially over this past year.  There are many reasons, and some may be outside your team’s control. However, with proper protocol development, site planning, and site selection, and accurate forecasting, you can mitigate some of these issues. Here are three of the most common clinical trial enrollment challenges ..read more

  Trusting a CRO to manage your clinical trial can feel a bit like asking someone new to care for your baby. You need to ensure they are competent, trustworthy, and reliable — and even after checking references and having a few conversations, you may still have some lingering concerns. We know the feeling because we’ve all been in that position before as clinical research associates. We know the stakes are high, and we’ve experienced the consequences of inexperienced staff or inconsistent processes in our previous roles. We welcome your questions, and we want to address them in this post ..read more

After more than a year of conducting clinical research remotely, many sites are finally reopening. However, they’ve also adopted new ways of working that are likely to continue.  Remote monitoring has the potential to offer greater flexibility and convenience while reducing costs in many cases. At the same time, some activities are still better suited for on-site interactions.  In a recent Device Talks Tuesday discussion hosted by Mass Device, IMARC President Brandy Chittester joined three other clinical research leaders to discuss the future of monitoring and some of the challenges ..read more

  We’ve talked about the challenges of working with large CROs, but it’s also possible for a contract research organization to be too small and limited in scope. The fact is that CROs vary in the scope of services they provide. Some CROs are what we call niche CROs, which means they provide only specific services, such as clinical monitoring or data management. You might initially think that’s all you need, but as you dive deeper into your clinical trial, you may realize you need support in other areas. By that time, it can be difficult to cut ties with your existing CRO or introduc ..read more

The past has taught us many lessons, and one of them is the importance of rules, regulations, and standards. The goal of Good Clinical Practice (GCP) is to apply these collective standards to protect patients. Let’s take a closer look at how history has shaped Good Clinical Practice, what guidelines it includes, and how GCP has changed in recent years ..read more

There are plenty of options for medical device manufacturers looking for a contract research organization to support their clinical trial. As smaller companies conduct more trials, the contract research organization (CRO) industry is expected to grow to $64.4 billion by 2027. However, this growth is accompanied by increasing consolidation. The top 5 CROs employ nearly 100,000 people and a single CRO can have thousands of clinical trials in progress at any time. Consolidation within the past three to five years includes a number of high-profile mergers. These chan ..read more

  Choosing the right contract research organization (CRO) is one of the most important decisions you’ll make in your clinical trial. The best CROs are true partners, supporting your study at every stage and ensuring compliance. In recent years, however, finding the right CRO has become more challenging as the landscape has evolved. The global CRO market is expected to grow to $64 billion in the next five years as new technology, big data, and a growing need to renew patents all increase demand. Here are three significant changes that could impact your choice ..read more

Clinical research monitoring today looks very different than it did just a year ago.  While many research sites were already conducting some remote activities before the pandemic, it was more the exception than the norm. Today, all signs point to a hybrid approach that combines on-site and remote activities.  ..read more

Although the new hybrid approach to clinical research presents many opportunities to reduce costs and improve collaboration, it also brings additional challenges, as our latest infographic shows.   ..read more

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