Contributed Commentary By Daljit Cheema

August 20, 2019 | Clinical Trial Management Systems (CTMS) have been around since the early to mid-1990’s. Used by biotechnology and pharmaceutical industries to manage clinical trials in clinical research, CTMS is an often-misunderstood software system. Many smaller organizations view CTMS as a discretionary system, its importance overlooked and not fully recognized. Yet it is a system that can maintain and manage planning, performance, and reporting functions, along with participant information, tracking deadlines and milestones—essentially the crown jewels of a clinical trial. So why are organisations finding it so difficult to harness the value of CTMS?

Historically, CTMS systems have had their challenges, being costly, complex, difficult to implement, and set-up, and deficient in integration. Classic systems can be heavy, clunky, and slow, lack intuitiveness and focus on too much manual data entry and rekeying of data that exists in other systems. Other operational systems can be used instead of CTMS, including spreadsheets and in-house developed systems, however they can often be burdensome to manage and lack compatibility. Disparate systems, non-standardized processes, siloed information and organizational boundaries all obstruct clinical trial management.

Over the years, CTMS has promised to ease the challenges of managing a clinical trial by providing increased visibility and data insights so problems can be addressed, progress can be made, and new possibilities uncovered. However, many have failed to deliver as they are not supportive of users that are in the field. As such, the market is ripe for change, and inventive approaches using modern technologies are beginning to emerge. As the healthcare industry evolves, companies demand smarter CTMS designed to simplify the management and control of clinical trials.

Today’s enterprise technology needs to be much more affordable, much more accessible, easier to use, quicker to implement, and deliver real value to those running clinical trials. Now, CTMS can no longer be viewed as a discretionary system, especially with regulators asking for increased governance of clinical trials and additional guidelines to follow such as ICH E6 R2. With CTMS it is possible to demonstrate every touchpoint of a clinical trial (CRO/suppliers/provider/external organisations) all captured within the system to fully demonstrate regulatory compliance. The value of CTMS as a tool for unified trial governance is rising.

To properly manage clinical trials, it is vital to understand the role of information within different technologies across all clinical trials and this is where CTMS comes into its own. CTMS is one of many systems that can be integrated with other technologies, such as electronic data capture (EDC) and interactive voice response (IVR) systems, enabling multiple technologies to be utilized within a clinical trial, streamlining workflows and improving productivity. Interoperability is a crucial factor of CTMS. Organisations need to be able to seamlessly integrate the CTMS with eClinical applications including EDC and electronic trial master files (eTMF). The import/export capabilities must be flexible to accelerate set-up and allow users to perform additional data processing, reduce manual data entry and reconciliation. This can all help improve clinical trial transparency to simplify registration with public registries such as ClinicalTrials.gov.

CTMS forms a cornerstone product across the lifecycle of a clinical trial, from initial budgeting and planning, to protocol development, compliance with government regulations, project management, financials, patient management and recruitment, investigator management and integration with other systems such as EDC and adverse event reporting systems. The objective is visibility into operational metrics and strategic management of clinical trials, with the goal of getting studies up and running quickly and smoothly and increasing the likelihood of success.

While having oversight of a specific clinical trial is crucial, the value does not start and end with each individual trial. The ability to deliver enterprise control across a portfolio of clinical trials is invaluable. CTMS can provide powerful business intelligence through features such as embedded dashboards and system reports across study management, payments, and administration. The ability to track study progress including enrollment, milestones, and essential documents, maintain organizations and associated contacts including global investigators and manage GCP oversight across flexible supply chains, provides the foundation for a corporate knowledge base. This master hub of information can be mined to track performance across clinical trials, and organizations can use the metrics to learn from and improve future studies. The ability to select and filter reports across study, country, and site generates a searchable, user friendly audit trail which supports regulatory compliance.

A CTMS should be adaptable enough to adjust to specific circumstances. With a flexible CTMS, it is possible to plan, track, and support global site and investigator payments, including multiple payees, manage multiple versions of site contract terms including fees and holdbacks, and schedule and trigger payment requests that can be tracked at site and study levels. The benefits also extend to trial design. CTMS can simplify the process of implementing and visualising high level trial design. It’s possible to tailor security for an organisation model with the ability to configure roles and permissions, use industry and company wide data across the portfolio to accelerate set-up, engage external contracted users/companies, reduce data duplication, and improve information consistency.

In today’s highly-regulated and increasingly-global life sciences marketplace, managing clinical trials can be extremely challenging. It requires an end-to-end system that offers oversight into trial costs and regulatory risks, while being flexible and compatible with other technologies. Innovative CTMS systems are engineered for change and offer extensive automation to deliver new features in a regulated industry, faster than current products. Intuitive systems that utilize flexible cloud architecture allow biopharmaceutical and medical device companies of all sizes to leverage affordable enterprise technology to fit their particular organization model.

Traditional challenges of poor usability, legacy applications, lengthy implementation cycles, slow innovation and costly maintenance can be overcome by CTMS systems grounded in agile flow-based engineering practices. By using CTMS to its best ability, it is possible to extract value from a process intensive and process orientated industry, ensuring increased governance on trials. Which is ultimately what everyone is striving for.

Daljit Cheema is founder and CEO of PHARMASEAL. Daljit led the Perceptive Informatics Technology division managing global software product development, IT operations and programme management driving strategic differentiation for competitive advantage, and was an integral member of the ClinPhone management team from 2004-2008 leading to a successful LSE flotation and subsequent acquisition by PAREXEL. Daljit founded PHARMASEAL in 2016 to create an integrated management platform to support the governance and control of clinical trials and provide enterprise technology that is highly usable, affordable and rapid to implement. He studied engineering at the University of Glasgow and holds a Master of Computer Science and MBA in Business Administration and Management from Imperial College London. He can be reached at daljit.cheema@pharmaseal.co.