22Oct2014computerFigure

Using Technology to Improve Study Startup

by Roshan Padbidri

SSU process improvement: a brief history

In the early days of contract research organizations (CROs), when just a handful of CROs existed, big pharma handled most of their own clinical development. With thinning pipelines and increased costs, there was a greater need for contracting services, and outsourcing activities expanded.

The 1980s saw an escalation in the number of CROs serving global biopharmaceutical companies. Although CROs began as small, specialized firms with specific offerings, by the late 1990s, study monitors or in-house clinical research associates (CRAs) performed all study startup activities, including all communication and document collection.

This exponential growth necessitated constant vigilance in CROs answering the questions: Are we continually scrutinizing our clinical trial process to best serve our customers? Are we improving on the processes that sponsors used before we came along?

Outsourced companies needed to operate in ways that were equally or more efficient than their sponsoring counterparts. They also needed to keep costs low in order to manage the increasing scale of clinical trial conduct.

As the traditional model was not sustainable, CROs developed a global SSU organization where fewer individuals were required to start a clinical study. Global oversight spanned multiple time zones and geographies. The problem with this model is that it created other challenges requiring more efficient and predictable solutions; there was a risk of continually reinventing the wheel. 

Technology in clinical study conduct

In its initial uses, technology always focused on the clinical study conduct phase, i.e., after subjects were enrolled in the study. Systems that came out of this included Clinical Trial Management Systems (CTMS), Interactive Voice Response Systems (IVRS) and Electronic Data Capture (EDC) systems such as e-CRF and e-PRO, study budgets, and monitoring operations. These were all specialized systems that didn’t look at the end-to-end study startup process or seek to eliminate redundant tasks between sponsors and CROs. Unfortunately, study startup functions never received significant attention from the tech world.

A changing landscape

As global and local CROs sought to work with the same clinical study sites, the competition grew. As a result, study sites became more adept at itemizing the costs of clinical trials. To this day, sites continue to request a trial sponsor’s fixed costs related to running a study (such as Internet fees, site coordinator salaries, etc.) rather than accepting an initially undetermined amount based on the actual work performed. Having to define the financial terms of the CRO-site relationship in this way makes a formerly straightforward and simple contract negotiation process complex and time-consuming.

Also, as new countries and sites continue to enter the clinical study arena, there is a growing need to quickly build skill sets and domain knowledge in study startup and regulatory practices. At the same time, with more local CROs proliferating globally, clinical study projects experience high turnover and instability. Bringing on a new resource requires a large time investment in training and hands-on experience.

The rising competition between global and local CROs. A lengthy contract negotiation cycle. Turnover and training roadblocks. Outdated processes. These challenges necessitate a technology solution that addresses all of them, at a minimum.

Embracing technology is an historical imperative for SSU

If study startup history tells us anything, simply adding more resources is not the answer. The deeper issues are process-based and can’t be addressed by an increase in human capital alone. Companies have to and are now leveraging technology to fill gaps in their SSU process.

For example, suppose a sponsor or CRO uses a technology-based solution to manage the standard setup process for clinical trial submissions to regulators and IRBs. In the event of turnover, the clinical study isn’t impacted because all information is housed in the technology solution. Knowledge is not lost, risk is dramatically mitigated, and the show goes on.

With the availability of real-time data, the project management team can focus on issues and bottlenecks affecting the clinical study. Time isn’t wasted assembling and discussing status updates; instead, all stakeholders view this information in real-time via their technology solution, well ahead of any scheduled status meetings.

Real-time alerts help decision makers intervene immediately or before a major setback has occurred, instead of after the fact. This is crucial, since in conventional study startup, intervention usually happens after an issue has occurred, when it’s too late to proactively avoid the problem.

All stakeholders can view dashboards and progress reports, without the need for a dedicated resource to update progress and status. This has a huge effect on the decision making process, as clinical study managers can now access automated,
at-a-glance status.

A better way for the 21st century

Think of the impact social media and smartphones have had on our daily lives, and the way we view and process information: we’re used to taps, clicks, and quick swipes. The days may soon be gone when someone assembles, reviews, prints, and delivers information to managers to discuss before decisions can be made. The push toward technology is a necessary quantum leap that provides companies with a competitive advantage, supports ever-evolving business processes, and firmly closes gaps caused by lingering inefficiencies.

See how CROs and study sponsors use technology to improve study startup.

 

About the Author

Roshan Padbidri is the Director of Customer Success at goBalto Singapore. With over 10 years of experience in the clinical research industry, he’s planned and developed global clinical studies in Asia, the Middle East, South Africa, Australia, and New Zealand. Connect with Roshan on LinkedIn.

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