Promising COVID-19 Study Supported by Lightning Fast eTMF Deployment

Aug 26, 2020 | eClinical, eTMF, Investor Watch, News, Phlexglobal, Regulatory Document Management

Promising COVID-19 Study Supported by Lightning Fast eTMF Deployment

Last month, TrialSite reported on upbeat results from a University of Southampton spinoff called Synairgen (LSE:SNG) and its stock price eruption after the UK venture, founded back in the early 2000s, produced positive clinical trial results for SNG001, its wholly-owned inhaled formulation of interferon beta. The study revealed SNG001 reduced the number of hospitalized COVID-19 patients progressing from ‘requiring oxygen’ to requiring ‘ventilation.’ With a focus on respiratory conditions, such as COPD and now SARS-CoV-2, the company recently opted for an electronic trial master file system from a private equity-backed British venture known as Phlexglobal. The result: a possible record-breaking deployment of an electronic trial master file (eTMF), going live in just 16 days. The dynamic partnership positively contributed to the sponsor’s study. The technology and the British vendor’s well known document management services arm now support the development of what could become a life-saving drug: SNG001 (inhaled interferon-beta).

Although still in clinical trials stage, TrialSite reported on the positive progress of SNG001 last month. Recently, a company known as Phlexglobal, backed by at least its third group of private equity owners, recently touted in a press release that they were able to plan, set up and configure Synairgen’s eTMF in 16 days. This is lightning fast, to say the least.  

Record Implementation

According to the press release claims, once Phlexglobal was selected as the preferred eTMF partner, the firm immediately went on to plan, configure and deploy the cloud-based system. Employing a “Gold methodology,” the project kick off commenced June 16, 2020 with go-live July 1, 2020 for a total deployment time of only 16 days. TrialSite can assure that eTMF deployments can run anywhere from 3 months to well over a year for large, complex firms.

Although Synairgen isn’t a big company, its’ not a brand new startup either. The company has an important pipeline and with the COVID-19 pandemic and the results thus far of SNG001, the rapid-fire eTMF deployment couldn’t have been timelier.   

Client Satisfaction

Pleasing biotech and pharmaceutical buyers isn’t easy. Notoriously demanding, with lengthy sales cycles and a myriad of technical, business, and compliance requirements, the barrier to entry in this market for technology vendors is high.  It isn’t every day that a client is willing to step up and share their thoughts in a press release. Hence comes the relevance of Jody Brookes, Head of Clinical Operations for Synairgen, commenting on the lightning fast eTMF deployment.  “Discussions with multiple people at Phlexglobal gave us the confidence that they were the right match for our company, our study and our very tight timeline,” noted Ms. Brookes. Emphasizing the importance of culture, she says, “Like us, they have a tremendous culture of innovation, and a spirit of genuine collaboration that has made a real difference in the project. Given the speed and quality of the service, going with Phlexglobal was absolutely the right decision.”

But Phlexglobal has come a long way since their days as primarily a document processing shop. What follows is a brief introduction to the eTMF market space and a 10K foot view observation of the transformation of Phlexglobal as a vendor in the global pharmaceutical industry ecosystem.

eTMF Market Space

Some of the backers of TrialSite have extensive backgrounds in clinical trials technologies, including eTMF. Hence, from time to time, this knowledge is imparted to the TrialSite network. The eTMF market was traditionally dominated by Documentum-based products or custom hybrid approaches (database software with collaborative file share and paper). Starting several years ago, Veeva gained momentum, first leveraging the Salesforce cloud-based platform to build out a replacement to Oracle CRM in pharma. The now staggering $40 billion market-cap Silicon Valley venture assertively moved into other segments of the drug development value chain, including eTMF, in which they now have established a market-leading position.

Evolution of Phlexglobal

Phlexglobal started off in the relatively sleepy domain of document processing services back in 1997—sort of like a contract research organization (CRO) for clinical trial document management. Important, albeit not high margin and certainly not glamorous. With offices in the UK and the U.S. and growing success as a service provider about a decade ago, the British venture sought that perilous transition into a high margin, high value “eClinical” software products company, naturally starting with an eTMF what was to become known as  PhlexTMF.

Hence, what was once a pure-play service provider hiring scores to process clinical trials regulatory documentation in back offices—the company appears to have made the successful transformation to something very different: a global technology player serving the global pharmaceutical industry.

This kind of accomplishment is not common, nor easy and should be recognized for its success. Most often, when pure play services providers seek to move into high margin product development, the risks associated with product development become too much for leadership to stomach: after all, they’re used to billable hours and utilization of 70% or more.

But in 2011, private equity firm Inflexion bought a majority of the company and higher margins and valuation was top of mind for British investors: product could make this happen. 

That transition, from paper processors to true clinical and regulatory technology solution providers first and foremost necessitates a profound shift in culture. This, of course, necessitates not only an open mind, brains and client connectivity but also self-reflection.

That the company even had a chance in such a transition came down to just a few impressive individuals in those early days. They were able to tap into and leverage its accumulating subject matter expertise and market connectivity, especially from its heavily networked business development lead Karen Roy, generating ongoing streams of important requirements; these, of course, ultimately materialized in the new product. However, more was needed from a leadership perspective to help with such a transformation.  

Board member Steve Kent joined in 2012, adding a whole new dimension to the nascent product company. Kent brought to Phlexglobal significant clinical trials technology pedigree combined with vital industry professional services acumen. Kent, who led Perceptive Informatics for a handful of years, actually brought the perfect combination of clinical trials technology and services experience backed by his years as managing director for Clinphone and then president of Perceptive Informatics. Kent recruited regulatory document management executive Rick Riegel as CEO in 2015, further transforming the culture from pure services to global technology and services provider to pharmaceutical companies.

Diversification

Now although the company has formidable competitors (Veeva, Open Text, Oracle, Dassault [Medidata] and others), thanks to the transformations previously discussed, the firm is now in a position to not only offer a commercially competitive eTMF but also new clinical and regulatory solutions. For example, its clinical trials solutions include CRO offering as well as archive offering for research sites (although it will have its hands full competing against Veeva Vault Site Free

In regulatory, the company has launched a product and services suite thanks to the expertise transferred to the organization from Riegel.  With a submission product, for example, now the company can mobilize technology and its well-known services operation to not only expand revenue opportunity but also build more retention opportunity for recurring revenue in regulatory operations. 

2020+

In 2019, the firm hired John McNeill (Sparta Systems, et al) as their CEO. This evidenced the Board and investors’ continued commitment to productization efforts—including the culture—as McNeill led Sparta Systems, which developed and markets one of the pharmaceutical industry’s leading quality tracking system called Trackwise

With an ongoing transformation in culture, evolving product lines offering greater diversification, a growing product client base, and the ability to expand into new areas in the drug development value chain, new private equity owner Vitruvian could experience a windfall in return on investment within a few more years should all of this come together in the right way. This company must contend with incredibly formidable competition but that client connected culture, nurtured by Ms. Roy a decade previous that cultivates lasting opportunity for further evolution. The Synairgen implementation certainly is a positive data point.

Source: Phlexglobal

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