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Trust and Clinical Trial Data: A Partnership More Than 20 Years in the Making

Trust and Clinical Trial Data
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For more than two decades, Medidata has been in the business of trust.

Today, more than 1,900 customers—including over 180 global CRO partners—trust Medidata to provide best-in-class solutions for capturing, processing, analyzing, and safeguarding their most important asset: patient data.

It’s a responsibility we take seriously. One that demands a steadfast commitment to following precise protocols, while also nurturing a culture of innovation that encourages people to explore and develop new technologies to make clinical trials more efficient, effective, and safe.

“I know it's a cliché, but I really believe trust must be earned,” says Tarek Sherif, Medidata co-founder and Life Sciences & Healthcare Sector Board Chairman for Dassault Systèmes. I think over two decades of collaborating and living through good times and hard times with the life sciences industry, we've earned a very high level of trust among our customers. And we’ve done so because we've listened, we've adapted, we've innovated…while always ensuring that security of their data is tantamount.”

Delivering Trust When It Matters Most

The COVID-19 pandemic tested the life sciences industry—especially clinical trials—in ways previously unimaginable. For those not fully prepared to conduct decentralized clinical trials (DCTs), running trials became nearly impossible with distancing requirements. Communication channels were disrupted and taxed. Clinical trial recruitment became harder to orchestrate. In fact, according to a Medidata study, there was an 80% drop in new patient enrollment rates during the early months of the pandemic.1 

These issues all pointed to the need for wider acceptance of DCTs to ensure trial stability during disruption. Unfortunately, it took a global pandemic to make that understanding resonate through the industry. According to McKinsey, in December 2019, only 38% of sponsors and CROs expected virtual trials to be a major component of their portfolios. In December 2020, that number rose to 100%.2

Despite all the obstacles the pandemic created, we knew coordinating and executing the clinical trials necessary to get vaccinations to market was paramount. And we’re proud to say Medidata was a key player in orchestrating COVID vaccine trials—including more than 4,700+ Phase I trials, as well the largest ever virtual trial—always making sure that the clinical trial data collected was secure and of the highest quality. 

Doing so forced us to tackle complexity with speed and agility, as well as increase our already intense focus on security. In 2020, Medidata blocked 614 million IP addresses and experienced just under 3 billion security events—approximately 8.2 million per day. The exponential onslaught was 100,000 times more than what we experienced in 2019, pre-COVID.

Medidata Trust & Transparency

 

“We were able to bring to bear the support of our leadership, as well as the talent of our entire team to protect the clinical trial data. And that allowed us to deliver the trials we were responsible for on time and in a safe fashion.”

– Scott Sumner, Vice President, Information Security, Medidata Solutions, a Dassault Systèmes company

 

A Legacy of Trust That Means Clinical Trial Data Transparency and Protection

But Medidata hasn’t always been a global institution that manages a wealth of data, generates AI powered-insights, enables clinical trial data transparency, and develops patient-centric solutions to solve the impossible.

The company began as a small, but ambitious startup. 

Over the past 20 years, the scope and scale of Medidata’s offerings have grown considerably, but its central commitment to customer trust has never changed.

Unlike organizations who design a trial and add security and privacy protocols after the fact, Medidata has always built clinical trial information security and patient data privacy into the design phase—ensuring clinical trial transparency that’s consistent throughout the trial lifecycle. Our “security-by-design”, “privacy-by-design,” and “quality-by-design” ethos means that these key components are built in at the beginning of the creation process.

Our core offering—the Unified Protection Strategy—has been designed to offer a secure, stable, and scalable cloud platform that provides robust data governance processes and an inspection-ready quality management system at every stage of a trial. Our goal is to make security, privacy, and quality both invisible and transparent to our customers—so you can rest assured that the data you entrust us with is safe and available.

To accomplish this, our continuous assessment programs—which include both internal and external auditing—are the most rigorous in the industry. We conduct more testing, perform more audits, and hold broader certifications than any other life sciences company.

  • We were the first life sciences company to receive the ISO 27701 certification—as close as one can get to a GDPR privacy certification today.
  • We are the only life sciences company to have the SOC-2 “plus”, covering security, privacy, and quality. In fact, we helped develop this unique certification partnering with PriceWaterhouseCooper.
  • While most companies conduct annual penetration tests—we conduct them every 90 days. The results are then posted for your review.

Our team of 45 security professionals monitor and respond 24x7x365 across 7 countries—handling 99% of issues within 5 minutes of detection.

“We spend a lot of time in the control functions, privacy, regulatory, compliance, and security, in front of the customers,” says Scott Sumner, Vice President, Information Security, Medidata Solutions, a Dassault Systèmes company. “We feel we're part of the intrinsic value proposition. People come to us for our brand. And part of that brand is the trust value proposition.”

 

“I am extremely proud of what our team is able to accomplish on behalf of our customers, regardless of the situation. It’s a testament to their hard work that we can deliver such high levels of security in even the most difficult environments.”

– Tarek Sherif, Life Sciences & Healthcare Sector Board Chairman for Dassault Systèmes

 

1. COVID-19 and Clinical Trials: The Medidata Perspective (Release 9.0), 2020
2. No Place Like Home? Stepping Up the Decentralization of Clinical Trials, McKinsey, 2021

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