November 15, 2011 | Mark Goldberg, PAREXEL’s chief operating officer, has been with the company since 1997 when he started the CRO’s medical imaging business. A radiologist by training, Goldberg ran a spin-off company from Massachusetts General Hospital in the tele-health space, which he helped to found. In 2000, PAREXEL created its technology business, Perceptive Informatics, as a majority-owned subsidiary. As Goldberg says, “we believed that it was an industry that grossly under-utilized technology and that this was a huge opportunity that would be important.” Believing that it could help differentiate their CRO service offerings, and importantly, help biopharmaceutical companies get products to market faster, in 2005, PAREXEL brought in Perceptive as a wholly-owned subsidiary, seeking greater efficiencies in the development process by combining an eClinical platform with clinical expertise.
Goldberg recently sat down with Bio•IT World chief editor Kevin Davies to discuss the importance of convergence in Perceptive’s suite of eClinical offerings, and to share his insights on the future opportunities, trends, and challenges facing the industry.
GOLDBERG: PAREXEL was one of the first clinical research organizations (CROs), founded nearly 30 years ago... We were born initially as a consulting business to help companies outside the U.S. navigate the regulatory environment. Eventually the company expanded into the core clinical research services, including monitoring, data management, medical affairs, biostatistics, medical writing, and regulatory affairs—all the core components of running a clinical trial.
We took the customer-facing technologies that existed within PAREXEL and rolled them into Perceptive, including the medical imaging business and interactive voice response systems (IVRS). We were also probably the first player to launch portal technology in the drug development industry. Portal technology was already used in other industries, but it was new to clinical trial management.
Today, PAREXEL is a $1.2 billion company and most of our revenue generation is derived from the conduct of clinical trials around the world. Perceptive accounts for approximately 13% of PAREXEL’s total revenue.
How has Perceptive evolved from its imaging roots over the past decade?
[Imaging] created the basis of our technology business. IVRS was introduced not only because it made it simpler to randomize patients in clinical trials but also because it allowed better management of investigational drug inventory.
Historically you would basically put a full supply of both the investigational product as well as placebo (or comparator) at all of the sites, with little ability to predict actual need. The amount of waste was enormous, because every site was treated like its own little repository. Using technology, and being able to predict and track how patients are randomized at the various sites, one could ensure that the inventory sent to sites was more appropriate to the number and mix of patients enrolled. In terms of other technologies, we have conducted EDC-based trials for many years, and built an industry-leading clinical trial management system (CTMS).
PAREXEL’s acquisition of ClinPhone in 2008 set a number of dominoes in motion. We were focused on bringing the first interoperable eClinical suite to the industry. Standalone systems were not well integrated and we saw an opportunity to really accelerate development... From a procurement standpoint, sponsors spent a lot of time trying to understand the different tools. The advantage was that by doing things electronically and eliminating paper, you could shorten cycle times by reducing query activity, locking databases faster, and so forth. But then, as technologies mature and you know that they work, the features and functionality among competing products become fairly similar...
We use the term convergence when we talk about similar trends in the eClinical industry. If you enter our eClinical suite through one of our applications, we expose the functionality of other applications without it feeling like you’re working with a number of different tools. It becomes much easier for the user. You can also eliminate extra work on the back end that used to occur around reconciling databases across the different tools being used for a given trial. I don’t know that any eClinical suite does absolutely everything, but we believe that ours covers the broadest waterfront. However it is still important for an eClinical suite to be designed to link easily with other third-party tools. You can never assume everything you have is everything you’ll ever need.
What other services does PAREXEL offer and how does technology fit?
When we are hired to run clinical trials, the purchaser is increasingly allowing us to make the decisions about what tools we should apply to do that work. Historically the client might have been very prescriptive about using certain technologies. Today, it is more likely that they tell us, ‘We want you to run the program, and you have the flexibility to recommend the best tools for the job—the ones that will deliver the greatest efficiencies.’ In that scenario, we have a strategic advantage because we have a full technology capability in addition to our clinical trial execution capability, which is unique to the CRO industry.
That said, we also sell our technology to other CROs. In fact, part of the reason that we preserve Perceptive as a subsidiary is because it makes it somewhat easier to support the full range of customers in the clinical trial business, including sponsors and other CROs.
Roughly 75% of PAREXEL’s revenue is derived from what we call CRS (clinical research services). That includes phase I through IV development. We offer a broad range of services from first in human and patient studies in early development to core clinical development programs, through and including peri-approval and post-marketing work. As I mentioned earlier, Perceptive contributes approximately 13% of our total revenue. The remaining 12-13% comes from our consulting and medical communication business. We probably have one of the oldest and most respected regulatory consultancies. We consult in a broad range of areas including strategic compliance, product development strategy, and regulatory affairs. We also consult in commercialization, which incorporates a focus on reimbursement and market access.
What areas do you see for big growth?
I think there are a couple trends to mention... We’ve been fairly provocative in the market in terms of our focus on having a convergent eClinical solution or suite. It’s built upon a platform of technologies that allows the various tools to intercommunicate readily, and relieves the customer of the need to deal with both integration work and also the reconciliation of disparate databases.
In our eClinical suite, we have the ability to leverage a broad set of solutions. This includes our IMPACT CTMS, which is still a market leader as well as our DataLabs EDC solution. We have the ability to provide IVRS for patient enrollment and study drug management—an offering that we refer to as RTSM, or randomization and trial supply management—and our medical imaging services remain a core offering. Perceptive does a lot of work around Web-based reporting tools in order to surface data from the various systems to inform trial management and decision making.
We also support electronic patient-reported outcomes (ePRO), although we have elected to avoid the hardware business for electronic diaries. Perceptive does provide consultation including help with design, instrument selection, and regulatory considerations. Where appropriate, we partner with technology vendors to provide whatever modality the client many need for data collection. We deliver voice based diaries ourselves.
As a $1.2 billion company, where do you go looking for new business?
We’ve always been a global business... We were one of the first to grow into Eastern Europe; we have a large presence in Latin America and in Africa. And we have one of the largest presences in Asia-Pacific, partly the result of the acquisition of a company called APEX International, which was the largest CRO in Asia-Pacific, in 2007.
Are there any downsides to global trials?
There is certainly complexity. You have to be experienced, have the knowledge and expertise to know how to execute in these various countries. I would say that there are a relatively small number of companies, like PAREXEL, that are credibly capable and have the experience to execute on a global scale using standardized processes. You have to understand the regulatory environment, the import/export rules, how medical care is conducted, and so on. And you have to have knowledge of the investigator community so that you know who can deliver quality data based upon a track record of high performance. The sponsor looks to us to be able to do a great job of selecting top quality investigators around the world. You have to have experience in these geographies and local expertise—real feet on the street.
Where are you finding new business opportunities?
Strategic partnering is really a new trend over the last few years, and gaining momentum. We are now considered a strategic partner of choice for a broad range of leading sponsors—from large pharmaceutical companies to mid-sized and smaller biopharmaceutical companies. This industry was historically very tactical in the way that it utilized outsourcing. In the past, a CRO would be called in if the sponsor had a shortage of personnel in a certain location or around a certain function. However, over time it became clear that these tactical relationships were fairly inefficient.
Strategic partnering is characterized by relationships where the sponsor will select one or two, typically large, global CROs, and will agree that their work is going to be split between these providers. Unlike a tactical relationship, in strategic deals ownership and accountability for delivery, and participation in design starts to become a shared event. It’s not just that a sponsor develops a protocol and asks the CRO to execute it for them. Now, we are involved in working together on the strategy, the cost, the trade-offs in terms of different countries we could go to, the inclusion/exclusion criteria for patients, etc.
What about new and emerging eClinical technologies?
The R&D focus has shifted more toward the convergence of the tools and providing a comprehensive eClinical suite, and somewhat less on new features and functionality. Of course, there is always development work going on, whether it’s for new medical imaging analyses or making sure we can support the latest imaging modalities. But I think the biggest trend has been investing in a platform that allows the various technologies to work seamlessly together.
Another trend would be the ability to leverage other kinds of datasets like electronic health records (EHRs), which have the potential to be helpful in a number of ways including identifying eligible patients. With the right search criteria, a database could be analyzed in an anonymized way to determine if there is an attractive population at a given site for a study. I don’t think that the technology and data standards are ready to support the capture of all of the data needed for a clinical trial from an EHR in the near term. I do, however, believe that we are going to see more and more use of EHRs for safety surveillance, and probably to support some types of observational research in the future.
That’s another one of the big trends we see—observational research... used to look for safety signals or to evaluate alternative treatments for purposes of comparative effectiveness.
From a reimbursement/safety standpoint, REMS—risk, evaluation, mitigation strategies—that are mandated by the FDA are increasingly relying on non-interventional or observational research. Our late phase technologies are being used in these settings to enable more efficiency.
What are among the biggest headaches or challenges for you?
I don’t know if I would call it a challenge, but we must always be vigilant to ensure that we are executing on time and on budget to appropriate quality standards.
One real challenge relates to the conduct of clinical development in some emerging markets. In some countries, one is entering markets where the investigators are less experienced and where you lack a pool of experienced talent. As an organization, to deliver reliably, we must take on an increased responsibility for training investigators, for training employees, and essentially building an industry where it did not exist before.
In this regard, CROs like PAREXEL have worked with regulators and government officials and the industry to advance the adoption of ICH-GCP in emerging markets for biopharmaceutical development.
Ultimately, you can be as good as the quality of the drugs that are going into man, right?
Our job is to provide high-quality research. We hope our clients are successful, but our responsibility is to conduct clinical trials that are adherent to all of the applicable regulations. Our job is to make sure that we do good science.
We believe that the CRO industry has an important role to play in innovating around how to conduct clinical research more effectively and efficiently. •
This article also appeared in the November-December 2011 issue of Bio-IT World magazine. Subscribe today!