Phlexglobal: Creating Innovattive Technology Solutions to Support Clinical Trials and Regulatory Submissions



Phlexglobal is a leading technology and services organization for clinical and regulatory matters with a focus on helping clients to master their digital agenda via proven AI solutions. The company’s mission is to help clients ensure that great research improves the lives of people by providing world-class technology solutions. Phlexglobal serves the life sciences industry through proven AI solutions.

Phlexglobal combines software and leading expert services to offer a unique solutions portfolio with easy-to-achieve automation via data generation that lifts organizations to a new level of effectiveness. The company innovates across all functions and roles. Whether its seeking new ways of working, developing innovative technology, or deploying new commercial models and customer engagement strategies, Phlexglobal is at the forefront of every trailblazing initiative.


From Traditional to Digital, An Impressive Transformation

Phlexglobal was founded in 1997 to provide the pharmaceutical industry with expert clinical trial staffing solutions. The company initially focused on Trial Master File support, a very complex and vital element of successfully bringing drugs to market. More than being an outsourcing provider, Phlexglobal became the leading authority on TMF management. As technology began to replace paper-based processes in clinical trials, Phlexglobal developed one of the first electronic Trial Master File systems, PhlexTMF. This system leveraged the experience of the company’s in-house expertise to build a model that could make the complex processes easier.

In 2020, Phlexglobal acquired Cunesoft, an innovative developer of intelligent software and expert services for regulatory data management. This move expanded the company’s portfolio of best-of-breed technologies designed to provide solution-specific functionality to meet the business objectives of life sciences companies. In addition to adding a full suite of Regulatory technology solutions, the move expanded Phlexglobal’s capabilities in Artificial Intelligence-powered Automation designed to streamline processes and improve quality.


A Leader with Aspirational Plans

John McNeill is the Chief Executive Officer of Phlexglobal. He took up the position in early 2019 and has provided strong, visionary leadership for the growth and expansion of the company ever since. Under John’s leadership, Phlexglobal has expanded its range, offerings to include pharmaceutical regulatory technology and services.


Infusing AI to Streamline the Filing of Trial Master File Documents

Bringing drugs to market is a complex endeavor. Phlexglobal provides support from the initial filing, all phases of the clinical trial, through to post-approval marketing authorizations.

Many regulations must be followed during a clinical trial. It takes expert knowledge and experience to ensure that a trial follows these regulations to protect the company’s investment and guarantee that life-improving treatments can help those in need. Maintaining a healthy Trial Master File is a major challenge to the industry. Phlexglobal has developed a disruptive technology to make this process easier. It provides expert services to streamline the process.

A major focus of Phlexglobal has been the development of artificial intelligence systems to augment the company’s technology to improve both quality and speed in the filing of Trial Master File documents. These tools have the ability to help customers achieve eTMF customers see double-digit time savings and 95% accuracy.


Leveraging ‘Best-of-Breed’ Technology for Better Outcomes

Phlexglobal takes a leadership position in the healthcare market and provides a clear sense of purpose to its employees. Since its inception in 1997, the company has made it a priority to bring the highest level of expertise to its solutions. As such, Phlexglobal leverages specialized ‘best-of-breed’ technology and services in which it can ensure the best possible outcomes for its customers.

Phlexglobal’s development of AI technology to support clinical development makes it a true innovator in the space. The company’s AI provides true, measurable results that increase speed and quality.


Praise from the Industry

Phlexglobal’s hard work and innovative perspectives have paid off in form of market recognition and powerful reviews from leaders in the life sciences industry such as,

Nancy Tappenden, Project Manager at UCL, on the decision to use PhlexTMF: “Having the support to make an organizational change to using an eTMF to ensure compliance with the protocol, local SOPs, and relevant regulations was of primary importance in the selection process. We also looked closely at whether the eTMF software could allow each of our four ICTM business units to retain control over its own portfolio of studies while strengthening every unit’s ability to collaborate with each other and with UCL’s many development partners worldwide. We were quite impressed by Phlexglobal’s capability to deliver on our requirements across the board.”

Sara Sorrentino, Senior Vice President, Client Services at Treximo, on the company’s decision to use PhlexSubmission: “There was a level of cohesion between our companies and alignment on the type of customer-focused solutions we provide. In tandem with the exceptional software provided by Phlexglobal, we knew this partnership would allow us to assist our clients in their full life-cycle of regulatory needs.”

Donna Chang, Founder, Hope Biosciences Stem Cell Research Foundation, on the decision to use PhlexSubmission: “We launched the Foundation this year to accelerate translational research in regenerative medicine so that therapies could be delivered to patients faster, ultimately by delivering high-quality data for quicker approval. With three Covid-19 protocols already approved, our team needed a solution provider to match our dedication to speed and quality, and whose submissions technology could meet our stringent requirements and growing trial portfolio. We found the right partner in Phlexglobal.”

Barb Hoff, Vice President at PRA Health Sciences, on the decision to standardize TMF practices on PhlexTMF: “Setting the standard for industry best practices, PhlexGlobal’s eTMF solution is designed for CRO and sponsor collaboration, which provides our customers with TMF visibility throughout the life of a project. PhlexGlobal’s TMF system is a market-leading technology that sets the standard for inspection readiness. The partnership with PhlexGlobal has provided PRA with valuable counsel and insights so that we are able to achieve the right alignment of people, process, and technology to efficiently manage TMF health and enhance our business offerings.”


Growth is the Goal, and People are the Key

Phlexglobal is a growing business. In order to continually adapt and ensure that the company can sustain its growth, Phlexglobal mustoutperform others with its solution offering and innovative approach. This requires great people who have the expertise and mindset to deliver great outcomes for Phlexglobal’s customers. Developing and scaling an organization is a key challenge so attracting, developing, and retaining great talent is key to the company’s success. But as a business, Phlexglobal is successful and is here to stay.


Moving into a Hybrid Working Model for the Future

The COVID-19 pandemic has helped many companies see the need to focus on solutions that help them to decentralize and modernize their approach to clinical trials. They are not just trying to avoid the risks that the pandemic has exposed, but also focuse on the benefits that digital technologies can bring to their trials. Phlexglobal will continue to develop and strengthen its services and technologies to meet the needs of the industry.

In terms of the organization, the employees have learned a great deal about how they can work and collaborate effectively. They will adopt a hybrid working model that allows Phlexglobal colleagues to create working arrangements that suit their circumstances, whilst ensuring they are able to collaborate brilliantly, learn from one another and sustain the company’s great culture.



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