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October 26, 2014

21st century clinical trial management

As clinical trials continue to grow in size and complexity, more and more companies are adopting software-as-a-service applications as an effective means of data management, without the hassle of building, and managing, their own IT infrastructure. Abi Millar looks at how Parexel International's Perceptive MyTrials platform helps to streamline electronic data capture, accelerate trial start-up time and improve monitoring through a single, unified platform.

By Grant Turnbull

Clinic

When the trend towards managing clinical trial data through a ‘cloud’ network first hit the scene a few years ago, biopharmaceutical service provider Parexel International responded with an eClinical platform called Perceptive MyTrials, the first of its kind to offer multiple capabilities under a group of applications.

Billed as a ‘fully integrated eClinical solution that simplifies the clinical trials process’, the platform promised to fill a gap in the market – which allowed users to use multiple applications under the same platform – doing away with integration challenges and workflow inefficiencies.

Two years on, the suite has continued to grow with added capabilities – most recently including Perceptive MyTrials Data-Driven Monitoring, which allows users to speed up the arduous patient monitoring process. Parexel International’s latest financial results, released earlier this month, speak volumes about its success, with the division responsible for the software-as-a-service (SaaS) application – Parexel Informatics – reporting a 17.3% surge in revenue in the last fiscal year.

One big, simplified environment for data management

Unlike other applications developed to manage the clinical trials process, the Perceptive MyTrials platform has a distinct advantage in that it was developed to be compatible with other systems, putting an end to users having to input the same data multiple times in different applications.



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Features that promote a seamless user experience – including a single set of credentials, which also enhances security – make the platform special, according to Xavier Flinois, president of Parexel Informatics. "It connects to other applications – whether they’re ours or not – in a very simple way, so that the users can go to the suite and feel that it is one nice big environment."

Because of the timescales involved in clinical drug trials, Flinois says creating an open platform was a realistic approach for Parexel to take as often clients will have used other applications for a specific activity, or may have even developed their own applications. Put simply, asking users to "start from scratch and drop everything" just wasn’t an option, he says.

"It’s a way to simplify the life of the users, or clients, so that they can actually focus on what they have to do," Flinois explains. "Very often in the case of clinical trials, it’s a long process, it’s cumbersome, so we are trying to bring in technology that makes things simpler, so it eventually results in a drug that can be commercialised."

Underpinning Perceptive MyTrial’s ability to streamline data capture, speed up trial start-up times and improve monitoring through its various applications is its scalability, which enables it to sustain very large-scale applications.

"We believe that with the coming of Big Data – a world where you’re getting information from a load of sources that come in big numbers – it’s extremely important to have things that are so-called scalable, which actually grow," says Flinois.

"The Parexel Informatics division has built a worldwide support network for users of the Perceptive MyTrials platform."

"Very few companies offer a platform that is scalable and open, which can actually be stitched to other applications, but can also provide enough functionality and point capabilities to actually help the sponsor from one end of the clinical trial to the other."

Accelerated trial start-up times

Clinical trials are often critical in terms of speed, and finding ways to reduce time-consuming tasks – such as finding patients and monitoring – is crucial when companies are up against the clock.

Flinois says that by using the Perceptive MyTrials suite effectively, users can save significant amounts of time, with two of the platform’s latest developments – the Perceptive MyTrials Data-Driven Monitoring solution and a new version of its Clinphone randomisation and trial supply management (RTSM) services – reflecting the need for enhanced productivity in what were traditionally long-winded processes.

"Technology helps by providing the right level of information in an easy-to-consume way to significantly cut the effort of the development of a clinical trial," he explains. "A sponsor may come to you and say, ‘I would like to find 2,000 patients around the world and I would like to start my study pretty fast’, and the type of technology we have here allows the user to go and find places where the patients could be and cut time by tens of percent by using the technology appropriately."

The company’s Data-Driven Monitoring solution, launched in May, is a prime example of how the platform aims to save clients’ time and money, while increasing patient safety. Taking an innovative approach to the process of monitoring – a critical aspect of trial management, which identifies and mitigates patient safety and data quality risks through investigative sites – the application captures, consolidates and organises clinical information in real-time to enable drug developers to identify study risks and quickly determine what type of intervention may be required.



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"Monitoring is a very time-consuming and potentially quite expensive exercise," says Flinois, but "greater insight into study data allows for a more precise determination of when on-site monitoring visits need to occur and what activities should be undertaken during those visits", saving time and money.

Parexel’s most recent introduction – the latest version of its ClinPhone RTSM services, released in June – addresses the need for efficiency at the start of a trial, when tasks such as patient screening, enrolment and randomisation must be initiated.

Through interactive web modules for patient, supply and site activities common with every study, the application standardises common functionality, resulting in simplified trial management activities that can cut start-up by weeks in some cases.

"The product allows the user to prepare the study much faster in terms of which patient is going to get what drug," Flinois says, allowing them to "ultimately start their trials more quickly, using the powerful and flexible RTSM technology".

Worldwide support infrastructure

With support from a company that has over three decades’ experience in biopharmaceutical services, the Parexel Informatics division has built a worldwide support network for users of the Perceptive MyTrials platform.

Covering clinical and technical requirements from early through to late phase studies, the call centre network – available 24/7, 365 days a year – provides support on clinical, executive, patient data and drug supply services, to name a few.

Since Perceptive MyTrials is used by some of the largest sponsors in the world, touching a significant number of worldwide trials, Flinois says the development of the support infrastructure was important for ensuring users feel that they are in "safe hands".

"Parexel International is seen as a very high-quality provider and products like Perceptive MyTrials contribute a lot to that," Flinois says. "Technology is becoming a very important and integral part of clinical trials – it can really make a difference in the development of new drugs."

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