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European Pharmaceutical Contractor

Gaining Access


EPC
: What was your entry point into the pharmaceutical industry?


Hunter Walker: My first job out of college in 2000 was with PRA (now PRA Health Sciences), a large CRO. Specifically, I supported regional clinical research associates for a Phase 3 Avastin trial.

About a year later, I started creating Microsoft Access databases to help manage several studies within the Clinical Operations department – essentially, these were small-sized clinical trial management systems (CTMS).

How has your role changed over the last few years?

As Atlantic Research Group has expanded its service offerings, we have required more systems to manage them. In the beginning, I would be the main point of contact for a given system’s administration. Now I focus on how we can better utilise the data stored in our various systems, in order to run trials more effectively.

Tell us more about your company’s mission.

We strive to provide small biopharma companies with the same technologies that large CROs are offering, along with the clinical expertise needed to fully utilise them.

What are the major recent developments in your field?

The huge jump in cloud-based service offerings, combined with the ability to provide valuable insights via analytics and collaborate on the findings. We have utilised cloud-based systems since 2004, but back then we had to explain the concept to virtually every new client. Today, the fact that a sponsor’s data is not stored at our physical location is no longer an issue.

How should pharma companies go about improving their data management systems?

By handling changes more rapidly and gracefully. Implementing a change for a study build within some systems takes a huge amount of time and effort. Our studies are built with electronic data capture systems that do not require a developer to code new fields, case report forms or edit checks. This type of drag-and-drop configuration greatly streamlines the change control process so we can promptly deploy changes, planned or otherwise.

What are the unique opportunities that cloudbased platforms offer?

Added security and easy deployment. I am not an expert on network or system security, nor do I have the resources to continuously monitor our system for vulnerabilities as software updates are installed. With no hardware on site, distributing access to users only requires an invitation to be sent to their email address.

You recently partnered with Comprehend – why did the collaboration come about?

An increasing number of our sponsor customers are struggling to access and integrate siloed data – data that is locked away in disparate systems and databases, and not easily accessible to all key stakeholders. Comprehend takes what is typically a very cumbersome and expensive process of providing valuable insights, and makes it fast and easy for sponsors to examine their data.

In your opinion, what is the secret to success in this industry?

Today, better data management and analytics is key. We need to move beyond warehouses that keep data locked away and departmentalised. By finding an effective way to make data accessible and usable, drug and device developers will have a significant advantage. To be competitive in this market, sponsors need to be able to leverage their biggest asset – data.

What is the one area for investment that holds the most potential in the next year?

Providing valuable analytics so that sponsors can gain insights into their clinical, operational and safety data via a cloud-based management solution will continue to be an area of interest. I think we have made real progress in this area over the last few years, but there are tremendous possibilities beyond what we have in place. As a CRO, providing a value-added analytics service is no longer a bonus, but a business imperative.


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Hunter Walker is Atlantic Research Group’s Chief Technology Officer, responsible for all clinical data management, safety, and data integration and analytics systems. He is the primary architect of TrialVista®, a proprietary CTMS that tracks, measures and reports on all clinical trial aspects.
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