Clinical Data Management - Cloud & Platform Agility for CRO Growth

1. Clinical Data Management - Cloud & Platform Agility for CRO Growth Smaller CROs are caught in a classic Catch 22 situation: to grow their business and reach, they need validated tools that will provide them with speed and agility; but to buy those solutions they need the revenue that will come from expanding their reach and customer base. To get around expensive systems and tools investments, these smaller CROs typically run early phase clinical trials using simple spreadsheets or non-standard tools in non-validated environments, hindering market access, the size of sponsor they can support, and the size of trial they can conduct. As soon as the sponsor company moves into more lucrative phase 2 and phase 3 trials, they immediately look for a CRO that has a validated tool set in place to support regulatory requirements –FDA, EMA, Japan’s PMDA and beyond. The small, regional CRO is simply left with the scraps, if anything. In the past, this might have provided enough work to get by. A clinical trial would be conducted in a region or country with fewer large competitors, allowing small companies to make a living providing early-stage support. A convergence of changes, however, is placing even greater pressure on those companies without the tools to grow. First, larger and even many mid-sized CROs are going global. They bring with them the validated tools and processes that allow sponsor companies to tap into the data more easily from the outset and extend their reach. As a result, many smaller companies have either consolidated or, unfortunately, gone out of business. Second, sponsors want rapid access to the data in real-time, or close to real-time, in order to determine the efficacy of the product, which will allow them to make rapid go/no-go decisions. Third, the limits of working on a spreadsheet or non-validated tool mean smaller CROs struggle to meet ever-changing regulatory requirements – the move to electronic applications, the push for greater transparency, data privacy regulations, to name a few. So where do small CROs go if they can’t afford the technology and they can’t compete without it?

2. For a technology solution to be truly agile and capable of supporting the needs of a growing CRO, it must go beyond point solutions; it must steer clear of complexity; it must remove the infrastructure headache from the CRO; and it must be a fiscally responsible solution. Deploying expensive on-premise servers will only exacerbate the problem, requiring small companies to develop entire IT hosting departments and staff. The answer to gaining this speed and flexibility lies in tapping into technology agility. That means lower barrier to entry, pay-as-you-grow, cloud-enabled, validated solutions that let the CRO get the solution they need, as they need it and pay for it as their business grows and, consequently, as their revenue expands. Advances in cloud capabilities remove the need for on-premise infrastructure or having the personnel to manage technology. So, as it turns out, the very technology advances that are leading sponsors to expect real-time data and regulators to expect more data transparency are also creating agility for CROs to grow their businesses. Agile also means simple to use and capable of supporting the business as it grows and expands. It’s all very well having clinical trial management software that gets CROs part of the way, but what use is that if it’s a closed-box solution that creates further roadblocks further down the line? To expand the business and enable partners to grow at the same time, CROs need to be able to add on components, such as electronic data capture systems, clinical trial disclosure systems and site-to-investigator portals. A pay-as-you-grow approach allows CROs to budget their technology in the same way they budget with their sponsor clients: on a study-by-study basis. This approach eliminates the disproportionate cost burden CROs could face as they ramp up their capabilities. As the CRO landscape continues to evolve and the demands on businesses tighten even further, the future – and indeed the very survival of small businesses – lies in agility. Having the building blocks that will let CROs integrate industry best practices with the solution and use the technology to help the business grow in other areas removes the limitations and allows CROs to compete, not only for a bigger slice of the pie in their region, but potentially expand into other regions and markets.