It’s a Bird, It’s a Plane...

By Michael Burton , Veeva Systems | May 1, 2014

Technology is extending the range of CRO “superheroes” and what they can offer clients.

The life sciences industry is undergoing radical shifts, and the contract research organizations (CROs) that take advantage of the new landscape stand to play a crucially important role. In search of greater efficiency, as the cost of getting drugs to market continues to rise, upwards of $1.3 billion last year, life sciences companies are increasingly turning to CROs for clinical trials1. In fact, clinical outsourcing was forecasted to climb to nearly $15 billion last year by Tufts Center for Study of Drug Development2.
There is also a clear trend toward CRO consolidation, raising competition for trials as the field narrows. In the emerging sponsor-CRO model, the world’s top pharma companies will move from 20, 30 or 40 different CRO partners down to just a few trusted partners to handle the bulk of their clinical trials. Baxter has gone from 20 down to just four CRO partners in the last seven years. Pfizer went from utilizing hundreds of CROs to just two: ICON and Parexel.

To remain competitive, CROs must be equipped and know how to implement strategic alliances, providing more services such as process re-engineering and technology implementation. The CROs that come out on top will be the organizations that demonstrate to sponsors that they are true partners. Fundamentally, this means enabling close collaboration, efficient information sharing and 360° visibility through the duration of the trial.  More CROs are using technology to achieve these goals.

Life sciences companies have struggled for decades to manage, effectively, the extremely high volume of documents and paperwork that must be exchanged between sponsors, CROs, and investigator sites throughout clinical trials. Paper and VPN-protected electronic systems are cumbersome and create blind spots between parties that slow down the entire process. CROs that streamline this burdensome part of clinical trials will not only improve transparency but will also dramatically speed time to market. These advantages will get noticed. In fact, CROs that consistently collaborate more effectively will earn the trust of the sponsor as well as preferred-partner status, as the organization that literally ‘saves the day.’ This will likely be rewarded with many clinical trial projects over as many years, so the stakes are high. 

To Build or To Buy? That’s the Question
As so many CROs are discovering, technology empowers them to open windows into the clinical trial process so that their clients can have that highly valued line-of-sight. However, as service companies, CROs must stay laser-focused on serving clients—how do you build a new system specifically designed for clinical trial support without taking your eye off the ball?

Building a custom system is daunting and can be a huge distraction from focus on the customer (that distraction increases when the systems require ongoing inhouse maintenance). Often, companies that try to build their own systems end up just reinventing the proverbial wheel, causing them to recreate problems that much of the industry already faces with legacy, on-premise client/server applications.

With these systems, each instance of software is installed separately on individual hard drives or an organization’s data center. As such, providing access to sponsors requires monumental effort by setting up secure VPNs, getting behind corporate firewalls, or even issuing separate laptops containing special (read: expensive) software. When CROs attempt to give sponsors the level of trial oversight they want, these technologies—implemented in an effort to improve operations—ultimately present yet another major obstacle.

Moreover, once CROs invest in building solutions on-site, the responsibility for system maintenance and upkeep falls to them. Updating these systems requires significant IT resources, so keeping pace with the rapid changes in the marketplace is a constant concern.

Today, however, CROs have more choices, including modern solutions designed to address the unique requirements of the life sciences industry right out of the box. These solutions are typically in the cloud and no longer “on premise,” meaning, the responsibility for implementation and maintenance falls squarely on the provider’s shoulders, freeing CROs to remain focused on what they do best. With cloud systems, the software is web-based rather than physically installed on site for easier access, information sharing, and collaboration. Cloud-based electronic trial master file systems (eTMFs), for example, are installed and maintained by the vendor and simply accessed by organizations through a secure web login. All parties can access and exchange documents in real time to create, review and approve documents directly within the eTMF at any time, from any location.
Cloud technologies can allow CROs to focus their resources on running better trials, rather than trying to become technology companies. Many cloud-based eTMF applications offer the functionalities required, out of the box.

Cloud Computing Is reaching a tipping point in life sciences, according to IDC
An increasing number of companies are turning to the cloud to improve clinical trial efficiency for their sponsors. In a 2013 report, IDC noted that the use of cloud-based technology has “reached the tipping point” in the life sciences industry for commercial operations4.Across the clinical spectrum, too, the cloud is gaining traction, with increasing adoption of cloud-based eTMF, submissions, and quality manufacturing systems.   Over the last six months, 20 life sciences companies have adopted at least one of our clinical cloud-based solutions. Organizations are moving away from their aging on-premise systems in favor of the greater flexibility and collaboration afforded by the cloud.

“As a CRO, we need our clients to review and approve many of our documents, so it’s critical that we be able to share them quickly and easily,” said Linda Danielson, chief operating officer for IDDI. “With our old system [a mix of paper and electronic], clients had to print, sign, and scan documents. They then had to upload the documents to a shared e-room or email them back—not an easy or efficient process. It was also difficult to track and to ensure that we received everything back. Our cloud-based eTMF enables effective collaboration between both parties, since sponsors can review, edit, and approve documents in real time.”

Cloud-based clinical trial support systems also offer the critical ability to scale up or down as needed. This is suited to the typical flow of drug development, as organizations must be able to ramp up operations quickly, to accommodate adding new trials, countries and sites, along with the greatly increased number of documents associated with these changes.

Applications with a multi-tenant cloud architecture have everyone running on the same version, so all parties receive regular automatic updates with new capabilities that they turn on at their convenience. When everyone accesses an eTMF in the cloud, it becomes the one secure repository where all trial documentation resides. In contrast, when content is kept in separate siloes, getting it into the eTMF is time-consuming and generates unnecessary costs, and sponsors aren’t happy with the lack of visibility.

Even when sponsors outsource trials to CROs, they are ultimately responsible to the FDA and other regulatory bodies. Therefore, sponsors want complete visibility into trial operations—a demand that CROs have struggled to fulfill. Historically, sponsors only had an indirect, partial view into TMF completeness often only receiving the final collection of documents after a study closed. Until then, sponsors did not have total transparency into how the trial was being conducted, causing sponsors to feel disconnected.

With cloud-based eTMF’s, CRO’s can provide tailored access so that sponsors can view documents as soon as they are ready, and continually monitor trial progress with dashboards and reports showing detailed document status, document quality and timeliness, and missing documents. Finally, CROs have the ability to assure sponsors that their eTMF is always inspection-ready and provides a single source of truth for trial documents generated throughout the entire study.

“A cloud-based eTMF gives us and our clients a strategic advantage,” said Julie Ross, executive vice president at Advanced Clinical. “We can speed document collection from start-up through trial close, and our clients get the visibility they need throughout the entire trial.”

Traditional document exchange, by contrast, lacks that open window, potentially creating confusion when the TMF is being readied for inspection. It also racks up considerable costs for CROs—collecting countless artifacts over the course of multiple trials that could each last years is a serious drain on time and resources. Just for a single study, a CRO prints, scans, and ships tens of thousands of documents. Slash these costs, and CROs improve profitability and can offer more competitive pricing.

The cloud also enables CROs to become a source of clinical trial performance metrics, from start-up to trial close. When clinical trial participants work in a single cloud-based repository of content, insights from across all trials give CROs visibility into some of the most labor-intensive periods of the study. This allows them to continue adding value beyond the trial’s end.

Who Will Save the Day?
Bringing insights together and having dashboards that surface key metrics can reveal hidden information, for instance,  what the most desirable sites are by therapeutic area, where consistent bottlenecks reside, or what processes are in need of improvement. Site activation, for example, is a major study milestone, and there are many points where the process can stall, leading to costly delays. As clinical trials become more dispersed, initiating them becomes a race against the clock, so organizations that can track such metrics as “task completion times,” and pinpoint these bottlenecks will have an advantage. Having access to detailed information on their own performance and that of their partners prepares CROs to recommend more accurate service level agreements (SLAs), operating level agreements (OLAs), and key performance indicators (KPIs).

Ultimately, the CROs that thrive will demonstrate the highest level of responsiveness to the evolving marketplace and the requirements of sponsors. The life sciences industry is becoming more challenging for all players. CROs have the ability to address their clients’ growing needs as an opportunity, so that they can have a more profound impact. In an ideal sponsor-CRO relationship, the CRO is both the sponsor’s main source of tactical support, as well as a gateway for innovations. New technologies can free CROs to focus on trials and improve their delivery by addressing some sponsors’ highest priorities.

“Greater externalization of what were once in-house resources and capabilities is occurring globally across all subsectors (biotech, small to mid-sized pharma, and Big Pharma),” said Andrew Brosnan, senior analyst, healthcare & life sciences at Ovum. “The improvement of IT-related cost efficiencies will be achieved through systems simplification and infrastructure consolidation, further cloud adoption, and increased external sourcing.5 

  1. FierceBiotech, “Biopharma’s Return on R&D Spend is Half of What it Was in 2010, report finds,” by Damian Garde. December 3, 2013 For the full report, click http://www.fiercebiotech.com/story/biopharmas-return-rd-spend-half-what-it-was-2010-report-says/2013-12-03
  2. ContractPharma, “Resizing the Global Contract R&D Services Market,” by Kenneth Getz, Mary Jo Lamberti, Adam Mathias, Stella Stergiopoulos of Tufts CSDD, May 2012. For the full story, click: http://www.contractpharma.com/issues/2012-06/view_features/resizing-the-global-contract-rd-services-market/#sthash.faHeFvlY.dpuf
  3. Applied Clinical Trials “Ovum Forecasts Global Life Sciences Technology Spending to Reach $40/8bn by End of 2017.” January 9, 2014. For the full story, click http://www.appliedclinicaltrialsonline.com/appliedclinicaltrials/News/Ovum-Forecasts-Global-Life-Sciences-Technology-Spe/ArticleStandard/Article/detail/832399?contextCategoryId=50216&topic=218,225
  4. IDC Marketscape Report, “Worldwide Life Sciences CRM Software 2013 Assessment,” by Eric Newmark. April, 2013. For the full story, click http://www.veeva.com/resources/idc-marketscape-worldwide-life-science-crm-software-2013-vendor-assessment/
  5. Forbes, “Whither Contract Research Organizations: A Glass Half Full?,” by Ed Silverman. March 29, 2013. For the full story, click http://www.forbes.com/sites/edsilverman/2013/03/29/whither-contract-research-organizations-a-glass-half-full/ 

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