Back in 1925, there was an outbreak of diphtheria in a small village in Nome, Alaska. It was a harsh winter and the only way to get the antitoxin to the village was by a sled dog team. The lead sled dog on the last leg of the serum run, one which transported the antitoxin from Anchorage to Nome and saved an entire village, was a Siberian Husky named Balto, our namesake. As the CEO of goBalto, Sujay Jahav cares about bringing significant technological disruptions to the historically inefficient and error prone startup stages in clinical trials.
There have been great strides in technology implementation in the conduct of clinical trials, but product development is still constrained by stubborn bottlenecks often linked to study startup (activities that occur before a study begins). This is widely considered to be the leading cause of long cycle times, which have stagnated for the past 20 years. Too often, if a study is improperly started, it requires rescue, which is a costly practice of adding more sites to complete enrollment targets. This is a big challenge as an estimated 80% of clinical trials fail to meet enrollment timelines. This degree of inefficiency leads to a 94% rise in study timelines.
The continual reliance on spreadsheets, multiple databases and unsecured emails without audit trial is inadequate to manage study startup activities. From a management perspective, the high degree of complexity results in valuable time being wasted—trying to find data buried in documents along with subsequent analyses that are notreadily available. In this environment, a multitude of status meetings to understand the results and key metrics driving startup performance is routine.
goBalto’s cloud-based platform accelerates the clinical trial process for pharma and contract research organizations (CROs), offering the industry’s only complete end-to-end platform for starting clinical trials, from site identification, feasibility assessment and selection through to activation, with comprehensive metrics to track adherence to timelines and budget. An end-to-end solution with workflows that aggregate data from the disparate sources can identify the documents needed to conform to downstream regulatory requirements and can also signal bottlenecks or breakdowns in study execution. This approach helps avoid rework, delays, and cost overruns; improves cycle times; and facilitates audit readiness.
goBalto Select assists with the identification of high-performing sites by providing a data-driven approach to weighing selection and performance variables, ensuring recruitment is completed on-time and on-budget. Chosen sites can then be seamlessly activated for subject enrollment using goBalto Activate, which enhances real-time oversight to clinical operations management by tracking milestones on the critical path, and providing document workflow management capabilities in a transparent, regulatory-compliant, and user-friendly way. Advanced and comprehensive reporting capabilities and real-time insights are provided by goBalto Analyze, providing visibility into study startup activities across multiple studies and countries, allowing proactive interventions and study optimization.
Under Jadhav’s tenure goBalto has experienced an incredible increase in usage, customer adoption and major enterprise adoption within the top 20 pharma and CROs, translating into multi-million dollar and multi-year deals. As of the last quarter of 2017, more than two-thirds of top 25 pharma and the majority of top CROs are working with goBalto in study startup.
Eager to improve study startup operations, industry-leading organizations are deploying purpose-built solutions with automated workflows that direct study team members through the various regulatory and organizational SOP requirements that are both study and country specific, as well as providing role management and alerts for tasks in a queue. These systems shed light on operational performance by capturing key performance metrics, which are essential for benchmarking and precursor to developing predictive analytics.
Automation has become critical for reducing the costs and complexities of clinical trials. However, it is not a panacea; rather, Jadav describes it as a catalyst to providing the performance metrics to empower business intelligence (e.g., benchmarking, predictive or forecasting projections), process optimization and efficient resource allocation, thereby improving proactive planning, overall quality and breaking down organizational silos. Automation also improves collaboration among stakeholders and holds the key for modernizing clinical trials, streamlining communications and enabling real-time decision making.
Despite the plethora of new solutions and approaches being deployed to reduce trial timelines, a fundamental bellwether of performance – the percentage of sites never activated – has remained at 11 %, a figure unchanged for over a decade. Technology adoption is not easy, and although these statistics are sobering, truly disruptive technologies exist, and opportunities abound for those organizations and leaders willing to challenge the status quo and bring about significant change.
Innovation is often cited as the “key ingredient” by organizations striving to sustain an advantage in the increasingly global marketplace. Technology adoption – particularly in a highly regulated environment – is a complex issue that deserves careful thought and consideration. Increased competition in the CRO market and pressure from pharmaceutical shareholders to rein in costs and improve financial performance are likely to force the hand of those waiting on the sidelines to streamline study startup.
Jadav believes that by continuing to drive industry awareness, supporting change agents and promoting the success of those early adopters, we can reset the expectations of all organizations involved in undertaking trials – empowering a learning process for incumbent or new clinical executives with such experience and knowledge, or those with just an innate willingness to change things for the better. Anything less will be unacceptable. As Jadav succinctly puts it, “Leading organizations outrace their competition by outlearning them.”
Cloud-based platforms that facilitate the flow of information among stakeholders help create a transparent and collaborative atmosphere. By ensuring global anytime, anywhere access study startup technology can bring measurable change at the inception of a trial, adoption of which will shorten cycle times, reduce study costs and, most importantly, speed delivery of new therapies to patients.