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With Medidata AI you’ll find the experience and the means to make it happen. You’ll discover a data resource like no other, transformative technology and people with a deep understanding of the challenges you face.  Whatever version of the impossible you are called on to solve, we can say, ‘Here’s How…’

We have the people to say ‘Here’s How’

Designing and delivering a clinical trial, launching a new medicine – these are some of the most complex and challenging responsibilities a career can bring. To partner with Medidata AI is to work with exactly the kind of people you’d want on your side.

“These decisions are as big as they come, how do I take the guesswork out of it?”

Customers of Medidata AI have the advantage of Intelligent Trials, a unique data and analytics platform that enhances decision-making across the full clinical trials lifecycle. Here’s how it works…

At the heart of it all are the combined insights of over 26,000 historic and ongoing clinical trials, 7.8 million patients and 30,000 sites across 107 countries. In the planning phase, our team works with the clinical trial data to optimize site selection and clinical trial enrollment decisions, providing granularity at every level – study, country, site, and investigator. Trial site ranking is based on predictive enrollment models across more than 130 indications. And as we build an optimal site footprint with our customers, we use proprietary metrics to mitigate against congestion with similar trials. Once the study is live, our team brings a competitive edge to decision-making with real-time tracking of performance against forecast, as well as benchmarking against competing studies.

“With so many variables, how do I stay on time and on budget?”

The ability to plot a course through complexity and variability is vital to the successful execution of a clinical trial. Here’s how the expertise and data resources of Medidata AI helped a trial sponsor do exactly that to support a critical Phase III clinical trial…

This top 10 sponsor’s trial was drastically underperforming in clinical trial enrollment. The sponsor needed answers and, more importantly, a plan to get back on track. Using our data and capabilities the sponsor was able to compare their study’s performance against other similar studies and changing industry conditions, site by site. The reasons for slow clinical trial patient recruitment were soon diagnosed and the sponsor developed a strategic intervention plan using advanced analytics to segment trial sites according to performance potential. Result: the study was soon trending towards an acceleration of six months or better.

How do you mitigate risk when you’re doing what’s never been done before?

Drug development is a high-stakes endeavor. There are many hurdles to overcome, and there is always the chance an unforeseen adverse event will bring the entire project to a stop. This jeopardy is greater for a novel treatment – a cell therapy for example – where there are more unknowns, and little precedent on which to base the clinical trial design. Here’s how Medidata AI can help…

The sheer scale and breadth of our dataset, and the analytic acumen we apply to it, means we can build models that predict which patients will be most at risk. Our customers are able to build their plans on a better understanding of the interplay between disease state and clinical trial risk potential. And because our dataset is a living, up-to-the-minute resource, our models respond dynamically as new data becomes available. Solving the impossible often means a journey into uncharted territory – and when it does, our data and expertise can light the way forward.

“How do you run a control arm when a novel treatment means so much?”

Patients recruited to a clinical trial know there’s a chance they’ll end up in a control arm. Too often, sufferers of life-threatening diseases – where standard of care may be poor – are inclined to back away or drop out. Here’s how Medidata AI solves the problem…

We devised the Synthetic Control Arm®. Using our unique access to historic, patient-level data from thousands of clinical trials, we can find trial patients who have received standard of care and match precisely the recruitment criteria our customers need. This allows us to design trials, with full regulatory approval, in which newly recruited patients have a dramatically increased likelihood of being on active treatment. Running a Synthetic Control Arm® helps our customers accomplish successful trials faster, more efficiently and with lower cost. More importantly, it means potentially life-changing new medicines reach patients sooner.

“When launch success demands world-class data analytics, how do you compete?”

You get one shot to get a launch right – and so much of a product’s ultimate potential can be decided in its first six months. In this complex arena, success flows from the ability to harness data and insights to make smarter decisions. Here’s how Medidata AI and our Commercial Data Solutions (CDS) team brought data superiority to a biopharma company launching for the first time…

The company had developed an infusion therapy for a rare genetic condition. For a treatment of this type, reliant on HCPs to administer and patients to adhere, it was vital the company could track any practical issues and respond swiftly. To do that successfully required a data operation of global stature that could pull in and digest information from a multiplicity of sources. By partnering with CDS, the company benefited from infrastructure and expertise on a par with much larger, more established companies. At a stroke, they gained the technology and know-how to process 400 data files from 40 data vendors daily – and turn raw information into insights in just two hours. Impressed by their new-found capabilities, the company engaged CDS to support two more launches. That vote of confidence from our partners is very much part of the CDS story; after 15 years and over fifty launches, 85% of our new business comes from referral. To work with us is to know.

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