The Promise of Tomorrow

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Linical partners with small and midsize biopharma firms on their unique treatment development journeys to support the well-being of patients everywhere

For decades, contract research organizations (CROs) have been supporting biopharma companies in their quest to develop new and novel treatments for virtually any condition or disease imaginable. The cost of bringing therapies from the idea stage to FDA approval is exorbitant, pricing small and midsize companies out of the market, stalling innovation, and keeping life-changing therapies out of reach for patients who need them.

Linical intends to change that. Rather than being all things to the market, they are on a mission to be the CRO of choice amongst the global midsized market, providing the full spectrum of drug development services from early stage to large-scale, multinational studies.

Headquartered in Japan with a significant presence across North America, Europe, and Asia-Pacific, Linical trains its focus on Phase I-IV studies in oncology, infectious disease, immunology, and central nervous system diseases. Linical operates several core service divisions; a full-service CRO, Pharmacovigilance, Pharma Resourcing including FSP Models, Innovative Drug Development Business (IDDB) focusing on Japan’s Market and Pharmaceuticals and Medical Devices Agency (PMDA) as a Business Unit, and a Clinical Contact Center to positively impact the advancement of clinical research.

Miguel Urrutia

Small and midsized biopharma firms require a different kind of partnership than the larger pharma companies do, and that’s Linical’s sweet spot. As CROs are scooped up in the frenzy of voracious M&A activities, large organizations are becoming behemoths; small boutique firms occupy the other end of the spectrum, but there are few that serve the mid-market. “We are in this unique spot as a midsize company to provide the hands-on attention that smaller and medium-sized clients want with their clinical trials,” said Miguel Urrutia, the company’s Chief Information Security Officer (CISO) since November 2021. Urrutia formerly trained on the FBI’s CJIS Criminal Justice Information Systems security program and is a former vetted member of the Miami Electronic Crimes Task Force. In his current role, Urrutia is responsible for providing strategic and operational leadership regarding the Linical’s Cybersecurity & Technology Operations.

That alignment makes Linical the ideal size to understand the development goals of small and medium-sized businesses (SMBs) and advise them on creating clinical study protocols to achieve their goals. Linical brings a significant advantage to the table, with global bandwidth that they wouldn't necessarily get with many other companies. “We can truly take their trial global,” Urrutia added.

The biopharma firms in Linical’s niche are seeking high levels of innovation and security. These days, potential clients have a greater focus on their partners’ security postures than ever before. Urrutia stressed that security consciousness begins at their front door. “We create that awareness within our internal employees that will then funnel through to our customers,” he said.

In addition to comprehensive workforce training, quarterly threat simulations keep them aware of the threat landscape. “We are always innovating on how to train in-house, leveraging cutting edge technology such as artificial intelligence and machine learning to help the organization be posture ready or cyber hygiene clean when facing the possibility of day-to-day attacks.”

Urrutia has a cybersecurity program that entails a partnership with critical cybersecurity vendors, such as Passpoint Security which provides artificial intelligence, machine learning, and monitoring to their offerings. In addition, the defense-in-layer approach includes offensive and defensive security teams to assist in yearly and quarterly risk management activities.

Urrutia credits the firm’s global senior leadership with ensuring that security is at the forefront of Linical’s business functions, missions, and objectives. Acknowledging that no organization can be protected from incursions 100% of the time, he said, “If we have the right cybersecurity tools, mindset, and culture, we can definitely mitigate a good amount of those threats and be able to protect the company and move it forward.”

That focus has a significant impact on the customer side as well. “When cybersecurity is viewed from the down-up approach, that's an uphill battle that 99% of the time cannot be won because there's not an executive level presence to help achieve their cybersecurity posture,” said Urrutia. He pointed out that all Linical’s internal accomplishments are achieved for one reason: to increase the success of biopharma research that is trying to improve human life.

Recognizing that small clients have different needs than larger clients, Linical has custom tools and systems to fit their specific needs, creating a secure environment where collaboration and efficiency measures can thrive. “It’s a top-down approach,” he said, noting the commitment of their leadership team to always be on the same page with their clients to apprise them on what their particular threat landscape looks like, and how Linical protects their customers and their data.

Internal Transformation Powers External Success

Recognizing that transformative business processes change the way companies work internally, Linical maximizes the use of tools geared towards their customers’ innovation cycles and business models. “What we do in Linical is special,” Urrutia said.

Cultural transformation is at the root of Linical’s commitment to cybersecurity, and that commitment extends from the workplace to home. They take a proactive approach, connecting the company’s security consciousness to the families and loved ones of the people who make the company what it is. That link, he said, helps loved ones be more proactive and better protected in their daily lives.

Linical leverages the cloud to transfer some of the security risks while staying on the cutting edge of technology. Having software programs on the cloud gives their clients robust redundancy, maintains compliance, and ensures that data can be accessed securely at the moment it’s needed.

Optimum efficiency and speed deliver enormous cost savings in the lifespan of clinical trials that advance life-changing treatments. However, with the preponderance of e-clinical technologies available these days, choosing the ideal tools and systems is essential. “We're all working towards the same shared goal of advancing these therapies. The key here is keeping these studies moving and choosing the right systems,” he said. Selecting the right platforms for each clinical trial such as Viedoc for data management and Greenphire for financial management is paramount to the trial’s overall performance and success.

“Just because the tool is out there doesn't necessarily mean it's the right fit for a trial,” he continued. Linical’s excellence in risk analysis, client collaboration, and matching the appropriate tools to a particular trial results in expedited, efficient, and safe clinical research.

Hands-on involvement is another important differentiator for the firm. “We roll up our sleeves with our customers,” Urrutia affirmed. “Sometimes this simple approach is not practiced in other organizations, which I find shocking,” he admitted, once again stressing the criticality of getting buy-in from their customers’ executive leadership to Linical’s top-down approach to cybersecurity.

The astonishing creativity of black hat hackers requires companies in all industries to stay at the forefront of threat assessment, and that’s especially true for CROs, whose clients are under the threat of individual breaches. “The importance of information security and regulatory compliance (i.e. GDPR, HIPAA, HITRUST) are paramount on many levels,” he said. Any disruption of a clinical trial can be tremendously costly for the organization, their clients, and, ultimately, the patients depending on treatments. “Everything we do to create this culture internally and externally for our clients is really key to keep these trials moving.”

“We all agree that the clinical trials landscape is changing. It's evolving with tech enablement to support the development of new therapies for patients around the world. As a global CRO, our role in security innovation is paramount to ensure there's no disruption,” Urrutia said.

That availability is a vital service to biopharma companies, as is the shared goal of improving all-around efficiency. “We want to be that trusted CRO partner that biopharma companies are looking for, all while working together to improve the patient experience.”