It’s a business cliché, but in clinical trials, time is quite literally money.

Developing new drugs and testing them in clinical trials is a lengthy and expensive process. Pharmaceutical companies hope that moving through trials quickly will get them to market faster – assuming their drugs secure regulatory approval. Technology has streamlined various pieces of the clinical trials process but clinical trials startup and patient recruitment practices are still stuck in the past, says Gordon Jones, CEO of Raleigh company Acorn Applications. Jones says his firm’s software can make clinical trials more efficient where they are least touched by technology: the beginning.

Every month, more than 10,000 sites begin a new clinical trial, Jones said. But he points to research compiled by the Center for Information & Study on Clinical Research Participation showing that nearly one third of those sites will never enroll a single patient. Another 20 percent of sites will enroll just one patient. That’s inefficient and it slows down clinical trials. It also costs money – not just the added expenses for setting up a new site and recruiting patients but also lost revenue. For each day a pharma company goes beyond the planned deadline for a clinical trial, that company could lose as much as $600,000 in foregone sales for smaller products and as much as $8 million on blockbuster drugs, according to Cary research firm Industry Standard Research.

Over the years, technology has been integrated throughout the clinical trials process. Electronic data capture software now collects data from trials. Trials are managed today with clinical trial management systems. But there is a reason that the startup phase of clinical trials remains largely unaddressed by software. Clinical trial startup and enrollment is not a linear process and can vary from site to site, Jones explained. At one site, the investigator won’t negotiate contract language until receiving approval from the institutional review board, or IRB, the board that reviews and approves plans for the trial. At another site, the investigator might work on the contract in parallel with the IRB review.

Software works well when A leads to B and B leads to C, Jones said. But at the start of a clinical trial, there are many different paths. Given the back and forth that can happen at this stage of a trial, systems just haven’t been designed to track and manage the disparate pieces of information.

“If you try to nail the process down and create automated workflows, there are just too many paths you can take and the structure just breaks down,” Jones said.

Acorn’s TrialSuite software has two pieces. TrialSite uses analytics to select the best sites to conduct a clinical for a particular therapeutic condition. Acorn has crunched data from previous clinical trials, such as which sites enrolled and which sites didn’t. It gathers information on the sites that did enroll, such as the number of studies previously done in a particular therapeutic area and the population density around the site. The software then compares those sites to other sites. Through machine learning, TrialSite figures out what makes a site good for enrolling patients in a particular therapeutic area.

The second piece of TrialSuite, called TrialCTA, manages the workflow of contracts, budgets and regulatory filing documents. Managing those documents to activate a site can be a 10-month process, which today is largely managed with spreadsheets.
Acorn offers TrialSuite via the cloud on a subscription basis. Putting the software in the cloud makes it accessible to everyone involved in the clinical trial – the investigators, the pharmaceutical sponsors and the CROs. Pricing varies depending on the number of sites and volume of patients, which Jones explains should make the software accessible to small companies as well as large ones. Acorn is targeting pharmaceutical companies as well as clinical research organizations.

Acorn isn’t the only company trying to address clinical trials startup. Some vendors sell databases of investigative sites. Others have developed software to manage workflow. San Francisco-based goBalto, for example, has software that manages the thousands of documents required for clinical trial startup. GoBalto counts customers including as Raleigh-based INC Research and Ireland CRO Icon. Clinverse, another Raleigh company, offers software that manages payments made to clinical trial sites and investigators. Jones says TrialSuite’s ability to analyze clinical trial sites and rank them in order of the best places to run a trial sets it apart from other clinical trials software offerings.

“We see the area as being wide open,” Jones said. “We think our technical approach is better and we’ll see success.”

Jones co-founded Acorn nearly two years ago. But the roots of the company go back much further. Jones and Acorn co-founder Jim Winburn worked together 20 years ago and kept in touch over the years. A discussion about using modeling techniques to reduce clinical trial costs revealed the inefficiencies associated with clinical trial enrollment. They founded Acorn to develop software to improve clinical trial enrollment.

Winburn’s experience includes 15 years in clinical trials. But Jones’ background is not in pharmaceutical industry technology. His experience comes from the manufacturing sector. Manufacturers use software to run models on projects to optimize operations. Jones has worked on projects ranging from hydroelectric power generation to supply chain optimization. He spent seven years in Asia working on planning and scheduling systems. Jones says the problems and inefficiencies he addressed working with those systems fit closely with the issues that pharmas encounter in starting clinical trial sites.

Jones and Winburn have self-funded Acorn to date. Acorn’s first client is Clintrax Global, a Raleigh firm that specializes in negotiating contracts for clinical trials. Jones said that Acorn’s software is also being tested by several CROs and pharmas who are conducting due diligence to determine whether they want to use the product. As Acorn works to build up sales, Jones said that he’s exploring seed-stage investment of approximately $500,000. Jones said he expects to hire two people for business development.