Medidata offers data collection, analysis, and presentation services for clinical trials through its cloud computing AI platform. The aim of the system is to reduce the workload involved in data handling and analysis. This can be considerable in clinical trials, where enormous amounts of data are generated from diverse clinical sites, making the resulting datasets challenging to assemble, analyze, and organize.

Medidata offers a secure centralized platform to collect and store such data, and also provides a data analysis and presentation service so that customers can see how the trial is progressing without having to crunch the numbers themselves.

Given the strict regulatory requirements surrounding clinical trial data, it is important that such data are recorded and interpreted correctly. Medidata provides regulatory-compliant services, such as audit trails and standard operating procedures, to ensure that this is achieved.

Previously, Medgadget talked with Kara Dennis, Managing Director of Mobile Health at Medidata, about Medidata’s role in handling clinical data generated by wearable devices. However, recently the company announced that Smith & Nephew, a multinational medical device manufacturer headquartered in the UK, has made the decision to host its clinical trials on the Medidata Rave Clinical Cloud. The company intends to use Medidata services to design and conduct studies globally.

See the video below for an overview of Medidata’s platform, in a keynote recently presented by Glen de Vries, President of Medidata.

Medgadget had the opportunity to ask Jackie Kent, SVP and Head of Product at Medidata, some questions about the technology and Medidata’s relationship with Smith & Nephew.

 

Conn Hastings, Medgadget: When and how did Medidata identify the need for a cloud-based data storage and analysis service for clinical trials?

Jackie Kent: Prior to Medidata, the process of running clinical trials, particularly how you manage and gather data, was very complex and manual process driven.

As a lab scientist himself, Medidata’s co-founder, Glen de Vries, experienced first-hand these inefficiencies. Both Glen, and co-founder, Tarek Sherif, knew that technology could improve clinical trials. Together, they built a SaaS solution that would help Medidata become the leader in clinical trial technology.

Medidata’s mission has always been to use advanced technology to help the life science community bring life-saving new treatments to the public. This started with Medidata Rave EDC, the world’s leading solution for capturing, managing and reporting patient data. Medidata continues to evolve and accelerate the science and business of research with a unified data platform that creates a trusted source for all study-related data.

 

Medgadget: Is Medidata typically involved in the planning stages of a trial, or do investigators approach you with trials already fully conceived?

Jackie Kent, Medidata: We are often involved in the study planning phase. Medidata is part of the entire lifecycle of clinical development, from initial study design to commercialization.

When a sponsor is designing their trial, they have an endpoint or outcome they expect. They design their trial to help understand the safety and efficacy of the therapy they are developing. Medidata can also provide data and tools that provide sponsors with insights into the trial designs. This includes patient burden, feasibility information, enrollment and more. We have data on our platform to help answer key operational questions and support the success of that trial.

We support this through a number of different solutions. Applications like the Medidata Rave Study Design Optimizer plug into our platform data to benchmark protocols against studies of similar indication and phase, enabling researchers to design patient-centric trials. The Medidata Rave Study Feasibility solution further leverages our data to identify the best-performing site facilities worldwide to support the execution of a successful trial. Additionally, sponsors can tap into our real-world data early on to better understand how to launch that product. The real-world data on our platform can also influence clinical design around enrollment and patient burden to increase the probability of trial success.

This data-driven approach enables rapid study startup, streamlined execution with cleaner data, and eliminates unnecessary reconciliation efforts to result in faster closeout.

Medgadget: What types of data analysis services does Medidata offer?

Jackie Kent: Two major differentiators for Medidata are our data assets and expertise. The Medidata platform is the industry’s largest structured, standardized clinical data repository with over 4.8 million patients. Our team of top data scientists, former members of the FDA and statisticians, not only optimize the value of this data through advanced machine learning, predictive models and natural-language processing, but also use their deep expertise to drive Medidata forward with unique solutions and services.

We leverage our industry leading expertise to automate the detection of problematic data points to improve data quality, reduce timelines and decrease regulatory risk. Medidata trains millions of data points with proprietary algorithms to boost signal detection and drive timely decisions on efficacy and safety during clinical trials.

We’re also in an ideal position to support new research approaches with synthetic control arms, by leveraging advanced analytics and patient-level data from thousands of historical clinical trials with our standardized platform data.

With SHYFT, we’re increasing the probability of success when designing and executing clinical trials. SHYFT’s data analytic and real-world evidence capabilities give the Medidata platform the ability to integrate third-party commercial data and real-world data sources, empowering our users to optimize protocol design and inform decision making.

Medgadget: Is the cloud interface easy to use for investigators? Do investigators request specific reports, graphs, and analyses, or can they generate these themselves?

Jackie Kent: Site investigators continue to struggle with multiple passwords. Medidata’s single sign-on allows the site to access patient information, and manage billing and operations during a clinical trial. With our unified data platform, site investigators only need to login once to view comprehensive patient data, including patient reported outcomes (ePRO), images and labs.

Medidata partners with third parties such as the Society of Clinical Research (SCRS) to ensure we frequently receive feedback from sites about technology and process. As part of this partnership, Medidata and SCRS are working towards a mutual goal of advancing operational excellence between sites and sponsors/CROs with the launch of Study Site Analytics Dashboard within the Medidata Rave Clinical Cloud. This will enable investigators and clinical research coordinators to gain insights into their performance relative to other sites in the same study in near real-time.

Medgadget: Please give us an overview of your relationship with Smith & Nephew. How will extending their use of the Medidata cloud assist their clinical investigations?

Jackie Kent: Smith & Nephew is a medical device company that is looking to expand its portfolio of advanced medical products. We’ve been working with them for two years, and recently they decided to consolidate all of their study management on the Medidata Rave Clinical Cloud. They will integrate their EDC and CTMS solutions so that data flows seamlessly, breaking down traditional data silos. This allows their teams to focus on oversight activities that are critical to the success of a trial, rather than spending time on data collection and integration. Consolidating on the Medidata platform provides them with a consistent, unified approach to manage all of their clinical trials so that they can grow faster.

 

Medgadget: Can you give us any specifics on the planned trials that Medidata will assist with in conjunction with Smith & Nephew, or ongoing trials?

Jackie Kent: Medidata will work with Smith & Nephew to design and build studies in the areas of orthopedics, sports medicine and advanced wound management.

Link: Medidata homepage…

Flashback: Cloud Tech for Life Sciences Research: Interview with Kara Dennis, Managing Director of mHealth at Medidata Solutions

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