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Tech Trends

A number of influences – predominantly the increasing pressure to reduce the cost and time devoted to managing processes, as well as the growing need for increased data standardisation and transparency to meet regulatory requirements – are driving biopharmaceutical companies to look to their CRO partners for innovative technology approaches to augment their clinical trials. However, factors such as the lack of standardisation across eClinical systems, scarcity of a skilled IT labour force, and the high cost of purpose-built technology solutions are limiting biopharma and CROs from aligning their long-term strategies and investments to more value-added activities.

Bending the Cost/Time Curve

To retain their value proposition for their clients, CROs are continually searching for productivity and value gains throughout the drug development lifecycle to positively bend the cost/time curve. Every year, biopharma companies and CROs spend significant portions of their R&D budgets on the management, support and integration of in-house application suites.

One of the key industry technology challenges that impacts the ability of CROs and biopharma to lower costs and decrease timelines is the number of independently implemented technology solutions available for clinical trials. The increasing cost of supporting and maintaining these technologies is affecting flexible growth options. As CROs and clients are independently entering into and managing technology relationships and contracts with multiple technology vendors, the cost of operational support for trials is rising.

Preparing for Trends

The trend of biopharma companies and CROs developing their technology strategies and roadmaps independently has resulted in an enterprise information portfolio that is made up of various disparate data warehouse and storage areas. These areas are served by a number of electronic data capture (EDC), clinical trial management systems (CTMS) and electronic trial master files (eTMF), as well as other data systems.

This disconnected approach is magnified when clients that work with multiple CROs receive both patient and operation data/reports in each of their partners’ formats, causing clients to manage their studies or programmes through these non-standardised processes. Additionally, while CROs are implementing processes and technologies that are flexible enough to meet the wide range of client requirements and standards, that same flexibility does not allow CROs to effectively optimise their internal processes for conducting clinical trials.

Improving Efficiency

The long-term costs of this technology curve will be difficult to sustain for biopharma companies that remain constrained by current tools that do not allow multiple CROs to access multiple systems. This holds true for CROs that do not expand their portfolios to include CRO-agnostic technology solutions such as software as a service. Including these solutions will provide the opportunity for multi-tenant data transactions and, as a result, deliver much of what is needed to clients in a consolidated view of clinical trial information.

A shift to cloud-based technology, with better and more modern integration capabilities, will enable CROs to deliver a more consistent and all-encompassing view of clinical trial operational and patient information, with the hope of decreasing costs and shortening timelines. This will allow drug developers to leverage their data in such a way that trials are optimised to progress as expected, and the best development decisions are made at the earliest points possible.

In the future, CROs will be able to focus their core competency of executing clinical trials and optimising and aligning their processes around pre-engineered CRO-agnostic technology solutions. Such a focus is a significant shift in mindset for CROs, and this ability to adapt and grow will serve as an important differentiator in the highly competitive drug development industry. CROs will have the opportunity to distinguish themselves by how they utilise these technologies and the services they provide, in conjunction with these solutions. This approach will allow CROs to leverage technology while focusing on their core strengths. The other option – one probably of lesser interest – would be to separate their technology offerings and adopt or align with an end-to-end eClinical suite offering, as a way to compete in the vendor technology market.

Leveraging Cloud Solutions

As studies continue to be executed with a mix of eClinical technologies – some based on personal preferences within clinical teams, others based on client-driven requirements – a new paradigm is emerging that will move the conduct and management of clinical trials to a standardised suite of cloud-based applications.

Virtually all technology conversations today include some consideration of such a platform and, in fact, many are used today, such as EDC and safety systems. The development of an end-to-end CRO-agnostic, cloud-based eClinical suite in which CROs and clients alike utilise a standardised core of applications for their EDC, CTMS and eTMF will have a far-reaching effect on enhancing collaboration between CROs and their clients. It will also allow for the sharing, managing and actioning of real-time data to become a reality, and help lead to an increase in productivity.

The cloud, too, is a technology advancement that biopharma companies are using to not only efficiently manage costs and reduce the time consumed in the trial process, but also to effectively accelerate innovation in their organisations. Embracing the cloud is an essential strategic decision for pharma IT leaders who are looking at technology as a differentiator.

Partnering and Investing

As CROs increasingly leverage their core competency of clinical development services, they are better able to work with technology vendors to guide the development and implementation of technology strategies to meet a variety of client needs. With this guiding strategy and by partnering with development vendors, the resulting individual innovative service technology relationships between CROs and technology providers will create solutions that will give clients access to a best-in-class CRO, as well as a vendor technology suite of the highest quality.

At its core, the envisioned suite would be a cloud-based, pre-engineered, end-to-end, best-in-class vendor technology application suite, wrapped in the CRO’s high-quality service offering, involving people, process and analytics (see Figure 1).

Telehealth Future

Telemedicine, too, is likely to challenge the current paradigm. While telemedicine is not new to medical care, if effectively managed, its use in clinical trials to overcome geographic barriers would be a disruptive innovation. It is likely that remote monitoring technology will not immediately displace the current way of doing things if used in parallel with current practices, although forward-thinking CROs will need to align their technology capabilities and processes around a solution that eventually will replace some traditional, essential study-related measurements.

The benefits of embracing the various telehealth technologies are far-reaching. CROs and pharma companies that develop study protocols to align with and utilise remote patient monitoring should expect to see an improvement in study personnel productivity, reductions in study costs, and higher patient retention and recruitment rates that far outweigh the cost to support and maintain these technologies.

Next Steps

Looking ahead, increased time and financial pressures on the lifecycle of clinical trials will continue to drive innovation in clinical trial management and the technologies used to support them for both CROs and biopharma. CROs and their clients have the opportunity to take an innovative leap forward and lead the industry in the use of data and technology, to simplify clinical development and create a culture of data-driven decision-making. This evolution will be led by widespread adoption of cloud-based technologies, standardisation and disruptive technologies that explore new ways to efficiently capture, manage and assess study data.

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David Blackman is PPD’s Business Innovation Director. Before joining the CRO in 2012 as Director of Enterprise Architecture and Business Process Management, he served as Vice President of IT Solutions Architecture and Business Development for iTPC in Durham, North Carolina. Previously, David also worked at IBM/ Lenovo, where he held a number of global technology leadership roles. A graduate of the University of Johannesburg in South Africa, he has more than 20 years of experience in development, process and technology innovations, and holds two patents and two patent applications for innovations in technology.
David Blackman
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