How to Improve the Speed and Efficiency of Your Clinical Trials

Situation

As clinical trials continue to grow more complex and the time they take to conduct gets longer, they are also becoming more expensive and hence the pressure on Sponsors and their partners to try to shorten the timelines and keep the costs under control grow ever greater. Finding new technologies and approaches to attain these savings, operational efficiencies and the most complete and accurate data possible, all has to take place in full compliance with regulatory and ethics requirements and as ever with a primary focus on patient safety.

Speeding the delivery of clinical trials and importantly the attainment of key decision points that both impact trial conduct, and more broadly, the Clinical Development plan, becomes more and more important. It is well documented that the rate of new drug approvals is declining by every passing year, either because it is not possible to show significant effectiveness or because unanticipated or excessive safety risks are identified. Clinical trials also often fall behind the planned timelines, both during protocol development as efforts are made to define study designs and endpoints to support successful conduct, and site selection as more and more effort is made to find sites that can actually find patients. These existing challenges plus the broader and newer challenges of increased complexity and costs all mean there is a real and present need to adopt and implement the latest technology and approaches to ensure as a research based industry, are collectively able to continue to speed the development of new medicines through to patients.

Technology is already here that can help significantly reduce costs and speed development. Over the past decade, there has been a number of technological solutions aimed at making the clinical trial process more coherent and efficient, such as moving from paper-based processes to the electronic data capture (eDC) systems now commonplace in the industry. But while eDC helps reduce a lot of the paper issues for the Sponsor, it does not end the paper issues for the sites, causing some frustration for investigators but also for Sponsors and their vendors who have to continue to verify that the data in the eCRF is in fact the same as the data recorded at the site. More recently, newer “eClinical” technologies have been introduced, but despite the new features and functionality these systems bring their own share of new challenges, constraints and inefficiencies. Hence, the Industry still awaits the real ‘game-changer’ that can both speed the operational delivery of clinical trials, enable new approaches to the monitoring and management of the data, all whilst enabling associated reductions in cost.

So a key question is, can technology really streamline processes, make the research team more efficient, improve patient safety, and get to the end result of the research faster?

Cmed has developed and now has the encapsia™ clinical data suite to do just this.

Improve quality, shorten timelines, increase productivity and reduce costs. Why wait?

encapsia™ is the new generation clinical data suite that utilizes modern cloud-based technology and its App based structure is designed to also run in the evergreen, mobile world experienced by consumers, but with the robust, GCP and computer system requirements needed for clinical trials to satisfy Regulatory Authorities. Fully portable and available on tablets for all those involved in the capture and monitoring of the data, encapsia™ allows you to collect, query, clean, visualize and analyze clinical data in real time, all within the one clinical data suite. Data can be captured using mobile eSource, or using web eDC via a very modern, fast user interface, including multimedia data such as photos, videos and handwritten notes to support remote monitoring and novel study endpoints. Powerful, configurable visualizations give you live “Actionable Insights” and immediate analytics of your trial to identify and analyze issues and trends easily and rapidly, reducing monitoring time, errors and cost.

encapsia™ delivers true advantages and the measurable benefits to Sponsors, Sites and Patients, including:

• Faster trial build
• Improved data quality with real time access
• Better, faster decision making
• More streamlined processes
• Reductions in monitoring frequency and time onsite Decreased site, DM and CRA workload
• Enhanced user experience at the site
• Reduced risk of errors
• Shorter trial timelines
• Lower cost of trial conduct

Proposition

The novel app based structure of encapsia™ includes an eSource app that can be downloaded via Apple Apps to work on an iPad, allowing online and offline capture of eCRF and other source data. It breaks a site’s bond with paper, and eliminates the time lost between a patient visit and clean, verified data being made available for decision making. In addition, encapsia™ Conduct also contains a complete clinical data management environment for performing all review and cleaning activities. You can configure any or all of the datapoints in your trial to be reviewed by any members of the study team, encompassing SDV, SDR, DM Review, Eligibility Review, and so on. The encapsia™ Loader app allows labs to quickly and simply create automated third party dataloads, while encapsia™ Review enables site staff to review and assess the clinical significance of lab data. These are just some of the many exciting new features of encapsia™.

In this webinar, speakers will demonstrate some of the key powerful components of encapsia™ live in action.

You don’t have to wait any longer to improve the speed and efficiency of your clinical trials.

Speakers

Graham Belgrave, Chief Operations Officer, Cmed

Graham Belgrave has over 30 years’ experience in the pharmaceutical industry with a strong background in global clinical development, strategy, clinical operations, outsourcing and project management. As COO, he is responsible for Cmed’s day-to-day clinical operating activities. Prior to this, Graham held senior positions at companies such as Grunenthal GmbH, Vernalis, Pfizer and GSK, and has worked in consultancy and interim management positions, including in Oncology at Roche. He is a Fellow of the Royal Society of Medicine (Oncology and clinical research sections) and he is an experienced chairperson, speaker and committee member of various industry congresses and symposia

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Sammie Rivera, Senior Client Services Manager, Cmed

Sammie Rivera has been in the pharmaceutical industry for almost 20 years, working primarily in Clinical Operations and Project Management across a range of therapeutic areas and world regions. Ms. Rivera currently serves as a Senior Client Services Manager within Cmed Technology, where she collaborates with clients to best utilise Cmed’s New Generation Clinical Data Suite, encapsia, to improve the capture and management of clinical trials. Ms. Rivera holds a Bachelor’s Degree in Biology and a Master’s Degree in Public Health.

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Jon Carter, Product Manager, Cmed

Jon Carter is Product Manager at Cmed Technology. He has been with Cmed for over 10 years and recently transitioned from the CRO side of the business to the technology division. Jon began life in Cmed as a Database Programmer where he built Timaeus Clinical Databases. He particularly enjoyed programming trials with highly complex and adaptive schedules. After doing this for several years, he moved to the Cognos reporting team where he led the team that enabled the reporting of clinical data from Timaeus through to Cognos. As a Product Manager, Jon is now responsible for creating the requirements for Cmed’s new system Encapsia and helps to drive the direction of the product.

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David Holloway, Global Head of Commercial Operations, Cmed

David Holloway is Global Head of Commercial Development at Cmed and recently joined the Company in February of this year. As a people focused business professional, David brings nearly 30 years multi–national experience in Clinical Operations, General Management, Marketing and Communications, Business Development and Project and Contract Management, all gained in organisations across the healthcare sector. David has held senior positions in Pharmaceutical Companies and Clinical Research Organisations in Europe, the US and South Africa and has also held management posts at the Royal National Orthopaedic Hospital and the UK Regulatory Agency.

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