Over the past decade, clinical trials have notoriously become plagued by problematic protocols, missed enrollment targets, and an unsettling level of redundancy and rework.

Only about a third of drugs that enter clinical testing ever progress to large-scale phase III studies and success rate could decline further if healthcare reform moves up the norm for proving value over therapeutic alternatives. Life sciences companies forced to abandon their traditional approach to drug development, suddenly find themselves on a quest for forward-looking operating model predicted on cutting waste and managing risk.

It is widely accepted that the current approach to planning and managing clinical trials is outdated. Clinical trials are a particularly costly and time-consuming part of the R&D process, frequently accounting for over 40% of total R&D spending.

More than 50% of clinical trials are easily behind schedule by up to six months. Not to forget that there is a tremendous cost involved with every day that a trial is delayed. This involves not just the product value, but the actual cost of running a trial on a daily basis which is estimated to be around 35,000 USD.

Common business process challenges faced by healthcare & life sciences companies

• Delays in analysis results, with not enough visibility on the process
• Data scattered among multiple systems, tools, and platforms, hindering the ability to make fast and well-informed decisions
• Paper-based business processes result in logistic nightmare for managing fresh requests and delivery of results
• Slow delivery of lab results
• Lack of visibility on request status (paper)
• Time-consuming, expensive manual processes for collecting data
• Unproductive back and forth between chemists and analysts

What’s the solution?

The industry is crying out loud for solutions that can mirror their own life cycle and development processes. Most healthcare companies are looking for systems that can start small yet extendable, addressing the needs of sponsors at a particular time. Systems that can be quickly altered, not just in look and feel, but also in their core logic and functionality. As well as systems that swiftly integrate with other clinical and cross-functional applications such as those employed by Manufacturing, QA, and Sales & Marketing. Sound too good to be true? Until recently it was. Most Life Sciences enterprises are still unacquainted with a new application paradigm that is rapidly being embraced by other industries to resolve their process challenges. This paradigm is commonly known as Business Process Management (BPM).

BPM & Clinical Trials

Steering a turnaround requires uniting and automating the business rules that drive corporate policies and procedures and navigating human resources, information and systems down the most direct and suitable path to their set goal. Interested study subjects – be they reaching out by telephone, email or web – might be whisked to an automated pre-screening tool. Additionally, BPM serves the information technology (IT) needs of companies that never had the wherewithal to invest in expensive clinical trial software in the first place. A robust, BPM-based clinical application can be constructed incrementally to cover all vital and interconnected tasks to meet productivity and effectiveness goals.

Along with improved workflows, the advantages include improved productivity, less errors and rework, enhanced confidence in regulatory compliance and less reliance on the IT department during process changing events.

How does BPM help?

1. Clinical Trials

Crucial process automation speeds up protocol creation and modification, containing clinical trial start up and management processes.

Data management optimization with a non-repudiable audit trail and compliance log, binds information and information from across an enterprise and partners into one, centralized repository.

Trial management is improvised leveraging a universal work platform across the enterprise.

Mobile collaboration and accessibility encourage and empower social collaboration and proactive innovation.

Easily customized forms & task types provide a distinctive experience for investigators to explore.

2. Compliance

Complete audit trail and compliance log recording every input and change on one BPM platform, enables a total compliance solution.

Enterprises can achieve total transparency in real-time, into all business processes, make compliance a state-of-mind and positive by-product of full accountability and visibility.

End-to-end reporting and distribution, including automatic access and denial to information set by role-based permissions.

3. Research & Development

Complete accountability and enabling exceptional collaboration across the enterprise leading to improved decision making and outcomes.

Improved productivity is attained from a centralized knowledge data store, gathered from across the enterprise, including partners, customers, and patients.

Decrease R&D “dead time” by automating manual/ paper-based processes, including reporting as well as distribution.

Enhanced competitive positioning by enabling faster execution and delivery.

Final Word

In the highly regulated industry of pharmaceuticals, many companies are turning to Business Process Management (Tools) to track, control and manage processes. One key area where BPM can make a huge difference is in clinical trials as they require extensive documentation and have lengthy and time-consuming procedures to be followed. BPM helps with this as well by automation of some of the critical processes and tasks. BPM also helps to document and track the overall process as well as the moving pieces to ensure compliance and accurate records. This can result in saved money as well as time as new products can potentially go to the market faster.

Over the past few years, we’ve collaborated with some of the industry’s leading pharmaceutical companies to add to their value chain and help them become future-ready with digital transformation. Our solutions resulted in:

• Improved efficiency, speedy market delivery and better outcomes in clinical trials.
• Digitized paper-based/ manual process resulted in time savings.
• Reduced constant back-and-forth between chemists and analysts.
  Increased transparency into lab processes.

Looking to know more about our digital transformation projects leveraging Bonita BPM? Download our customer story.

Evoke Technologies’ BPM services

Change and intricacy are the bywords within the pharmaceutical industry. Evoke Technologies addresses these issues with stunning simplicity, rendering change management easier to implement, yet encouraging collaboration and innovation.

Leveraging Bonita BPM platform, we have helped our pharma clients leverage information quickly and effectively, drive efficient processes and greater success. We also offer an array of digital solutions that help life sciences organizations improve clinical development processes, improve data quality and boost business outcomes.

By streamlining varied processes, we help speed up clinical trials, strengthen research and development, ease compliance, and improve success rates. That’s where smart business process management services from Evoke Technologies can help optimize clinical trials effectively.