A service provider was using an in-house clinical development software solution to set up clinical databases to record and analyze trial data. Modifying or updating the system required personnel with coding and development skills and implementing revisions—amended versions of the clinical database—to trial protocols took time that could interrupt data input and reporting, and slow down trial completion. the IBM Clinical Development solution offered the clear choice for designing and managing a study that included a complicated patient visit schedule, multiple tracks within the study groups, and an open-ended and variable patient participation timeline.

A full-service CRO that helps pharmaceutical and biotechnology development firms complete clinical trials and prepare regulatory submissions to the US Food and Drug Administration (FDA) and other regulatory agencies for approval needed an EDC solution that it knew could support a wide variety of studies and study parameters. The IBM® Clinical Development solution armed them with a powerful clinical research platform that provides fully integrated advanced modules, such as medical coding and randomization, that help the organization continue to simplify clinical study processes and increase overall trial efficiency.

A contract research organization (CRO) focused on quality needed to more thoroughly document clinical studies for sponsors, regulatory authorities and other auditors. With a cloud-based, unified IBM® Clinical Development platform, the CRO can now quickly create accurate digital records of every action taken, including granting users access and updating study protocols.

A CRO was in search of a data science partner that could potentially shorten the development lifecycle of the drugs the CRO was helping to get to market and do so at a reasonable cost. The IBM Clinical Development solution allowed them to complete their study build faster, which ultimately reduced its average EDC deployment to a 4 – 6-week timeframe.

Southern Star Research needed a technology platform that would allow its data managers to rapidly build and deploy clinical studies without the help of IT staff and programmers. The organization successfully built a comprehensive and ready-to-launch study in four days by partnering with a solutions and services provider.

External control arm (ECA) studies, which use patient-level matched unexposed controls to create a comparator cohort, are being increasingly utilized to supplement the control group in a randomized trial, or to replace the control group entirely. As a consequence, many organizations are eager to understand the purpose, feasibility, and potential applications for these types of studies as part of their clinical development strategies.

Where a combination of traditional trial expertise, technologically savvy- insightful dialogue with patients, and pragmatic processes, are required to successfully execute a hybrid or virtual clinical trial.

Pharma companies continue to seek ways to streamline their operations, and clinical trials were a common target in 2020 due to COVID-19. As anyone involved with clinical trial operations or data management can tell you, medical coding is an often-overlooked element of the process that is ripe for improvement.

As clinical trials become more complex and costly, life sciences organizations need a solution that supports all clients, phases, and industries. By leveraging IBM Clinical Development, both CROs and sponsors have achieved groundbreaking advancements in study speed and process, delivering faster therapies and innovations to their patients. In this session, hear from an innovative CRO and a large sponsor, both avid users of ICD, on how their businesses have thrived since implementation.

The COVID-19 pandemic further exacerbated some of the challenges associated with clinical trials, but it did fast track the adoption of decentralized trials as well as some of the associated technologies, like the consent process, that enabled subjects to more easily participate remotely.

A technology or solution created with thoughtful, strategic design will elevate the experience of the user. By applying the strength and worldwide reputation of IBM design to clinical trial technology, the company is set to revolutionize — and significantly improve — the experiences of both patients and site personnel.

As pharma companies and CROs around the world continue to adapt to running trials in this new COVID-19 environment, they are taking this time to reassess the status quo of their technology installations. It’s times like this that you can really delve deep into assessing how “open” or “interoperable” a system really is.

A paradigm shift is underway in the world of clinical trials as more and more CROs and pharma companies investigate some type of decentralized trial. The adoption of novel approaches has been slow, but the COVID-19 pandemic has changed everything.