New Report: Contract Delays Cost the Average Clinical Trial Millions. Contract Management Software Can Help.

By Neal Singh

Today's pharmaceutical and biotech companies are grappling with complex drug trial processes, highly regulated promotional programs, and complex supply chains. At the heart of all these challenges are contracts.

A new survey by WBR Insights bears this out and shows that contracting continues to be a challenge for many organizations. In Q2 2019, WBR Insights, in conjunction with Icertis, conducted a survey of 100 Clinical Trials Managers in the EU to find out more about the challenges they’re facing in operations today. Contracts and contract processes emerged as a central theme.

Most notably, 60% of respondents said delays in contract and commercial negotiations cost the average drug trial 10 million euros (about $11 million); 20% reported negotiation delays costing each trial more than 50 million euros (about $55 million).

Manual Contract Management: A Known Challenge

This is hardly a new trend. According to the Association of Clinical Research Professionals, contract and budget negotiations are responsible for 49% of study delays.

Common outcomes of manual contract management processes include:

  • Difficulty in meeting study timelines and milestones
  • Strained relationships between sponsors, CROs and sites
  • Difficulty in accurately tracking budgets and consumption
  • An increase in the cost of taking a drug to market
  • Lack of real-time, end-to-end visibility across the clinical trial process

Contract Management Software Is Key

But these are not insurmountable challenges. Contract management software is the key to accelerating, protecting and optimizing clinical operations.

Below are three main takeaways from the new report, and insights into how contract management software can help.

1. Contract Negotiations Delay Time-to-Market


It's often taken for granted that contract negotiations will delay time-to-market for pharmaceutical companies.

Yet with an enterprise contract management system that supports automation of the entire contract lifecycle, contract delays are eliminated with a streamlined contract management process. Enterprise contract management platforms can include tools like a collaboration portal that allows third parties to have secure and controlled access to documents for seamless communications, intuitive redlining capabilities, and full visibility across all channels. No contract issues surprise stakeholders at the last moment.

2. Increased Costs and Strained Relationships Are Common Fallout from Manual Contract Management


Enterprise contract management software is the key to addressing challenges related to delays and strained relationships. An enterprise contract management system connects the contracts involved in a given trial and provides powerful tools to manage clinical trial agreements and track budgets.

The Icertis Clinical Trial Agreement and Budgeting app, built on top of the Icertis Contract Management (ICM) platform, ensures the right language and templates are used for site contracting and gives companies easy access to information like on-site history to accelerate turnaround times. It also tracks payments and milestones throughout the lifecycle of the trial.

ICM drives visibility by capturing and tracking research budgets, and integrating with financial systems to create a holistic view of the entire drug trial process. Budgets can be accurately tracked against contract commitments, and obligations can be fully managed to ensure all partners are meeting commitments to drive down costs and deliver on time. Configurable dashboards and artificial intelligence provide critical real-time data on cycle times, potential risk, compliance challenges and other key metrics.

3. The Costs of Contract Delays Are Staggering


The fact that contract delays are costing companies more 10 million or even 50 million euros per trial underscores why enterprise contract management is a must-have for today’s pharmaceutical companies.

Enterprise contract management applies the power of the cloud and artificial intelligence to contracting so that companies can accelerate the process without incurring regulatory risk. This is why analysts consistently report the high ROI for enterprise contract management.

AI-infused contract management software drives efficiencies in business negotiations so that pharmaceutical companies can focus on bringing innovative, life-saving drugs to market at less cost and higher speeds.

Want to learn more? Download the full WBR Insights report here.