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Automating study start-up enables faster site activation, better collaboration with study partners, and more informed decision-making. That’s why sponsors and contract research organizations (CROs) are turning to technology specifically designed to manage the intricacies of study start-up.


Effective Study Start-up Technology Transformation

Learn how you can improve cost and process efficiencies and make it easier for pharmacovigilance teams to perform advanced tasks.

Key Considerations When Evaluating Pharmacovigilance Solutions

1) Data will flow more seamlessly between clinical trial systems and stakeholders.

	As the number of data sources in clinical trials rises, companies will look to streamline the flow of data and information between stakeholders and systems.The airline industry is a prime example of connecting data automatically. For instance, flight delay information is immediately available via airport screens, mobile applications, and online. Data is shared across multiple, separate systems so travelers have access to the latest information, regardless of location or channel.

	This is where we are heading in life sciences.The cloud will enable clinical data management teams to see all of their data in real-time and easily share information with stakeholders. Organizations can bring their data together and move toward risk-based trials-where data is collected and analyzed throughout a trial-for a current, holistic view of the patient. The result will be better collaboration between clinical sponsors, CROs, investigators, regulators, and even patients.

Automation of clinical data exchange will increase for improved stakeholder collaboration.

	In 2019, the industry will move closer to automating clinical information exchange. While sponsors, CROs, and clinical research centers have access to more technology than ever before, it remains difficult to share information with one another. As a result, clinical trial collaborators will begin to bring their technology and processes together to automate the exchange of clinical information.

	In the last few years, there has been significant industrywide momentum toward a unified clinical operating model, with the need for better collaboration as a major driver. In fact, 87% of clinical operations professionals recently reported that they plan to unify their clinical systems, citing internal and external collaboration as a primary reason for the initiative.

This year, sponsors, CROs, and clinical research centers will prioritize eliminating communication barriers and automating clinical data exchange with cloud-based technology.

Clinical research centers will play a greater role in speeding clinical trials and driving higher quality studies.

	This year, there will be greater demand among sponsors and CROs to find and partner with high-performing clinical research centers as the pipeline of new treatments for rare diseases continues to increase. The heightened focus on specialized drugs and the rising cost and inefficiencies associated with clinical research will cause sponsors and CROs to rely on a more diverse set of clinical research centers than ever before. This, in part, will prompt clinical research centers of all types to increase investment in developing their own infrastructure, including people, processes, and technology, to standardize across trials and help accelerate end-to-end trial execution.
	
	Historically, sponsors and CROs have driven this investment, often resulting in clinical research centers needing to use a minimum of 12 different electronic systems to collect and capture clinical study information.

Looking ahead, expect clinical research centers to drive a larger portion of this investment, and sponsors and CROs to rethink traditional business and financial models to enable this shift.

The medical device industry will move clinical trial management to the cloud.

	The new Medical Device Regulation (MDR) in Europe will prompt medical device manufacturers and distributors to leverage the flexibility and cost-efficiencies of modern cloud-based clinical systems.

	The MDR requires more clinical evidence and technical documentation, as well as a greater focus on identification, traceability, and market surveillance. This will cause a jump in the number of clinical studies conducted,affecting costs, processes, outsourcing strategy, and even organizational design. Device manufacturers will turn to new solutions such as electronic trial master files and clinical data management systems to compliantly and efficiently go to market.

Veeva 2018 Unified Clinical Operations Survey

	2. “New CenterWatch Study Finds that E-Clinical Technologies are Increasing Investigative Site Work Burden and Performance Inefficiencies,” CenterWatch, 2016, 

https://www.centerwatch.com/press/pr-2016-05-17.aspx

Veeva Systems

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