The pharmaceutical industry’s bias for doing everything in-house has been replaced by a growing preference for outsourcing non-core functions. Global drug discovery outsourcing alone - an $8.2 billion market in 2010 – is projected to reach to $21.2 billion this year [source: Kalorama Information].
Contract Research Organizations (CROs) support the pharmaceutical, biotechnology and medical device industries - performing R&D and clinical trial activities. The rationale for this externalization of research is lower expense, greater efficiency, and greater agility and resourcefulness for the sponsor.
An Impact Report from The Tufts Center for the Study of Drug Development found that - on the clinical side - not only had global spending on CROs increased 15 percent annually, but projects with high CRO use were submitted more than 30 days closer to the projected due date than low-CRO-use projects.
Distributed research is not without challenges, however. Outsourcing and partnering present some hurdles that both sponsors and their CRO partners must overcome:
• Discovery pipelines live in many hands and minds outside the sponsor company
• Entire teams must benchmark performance and quality
• Data and services must be integrated across vendors
• Data silos and fragmented intelligence still exist
• Organization and management are difficult
• Stakeholders experience communication lags
• Concerns remain over data security and IP protection
Outsourcing & Partnering Can Challenge the Control & Analysis of Data
Pharmaceutical sponsors can find themselves with too many collaboration partners, and no easy, secure means to connect and communicate with them in near-real time. They may work with more than one CRO, or CROs with multiple or remote locations (a growing number are in China), making it difficult to maintain control over data and to share results.
CROs also work with multiple sponsors, which introduces competitive and IP concerns. Outsourcing partnerships can be long-term relationships, but individual projects are often limited-term engagements. This leaves sponsors looking for a way to connect everyone involved in the project – internally and externally – but only for the duration of the project.
Much of the communication between sponsor and CRO today takes place through email. Not only can that introduce delays, but valuable data assets are floating in cyberspace with little to no controls.
For outsourcing to succeed in driving innovation, reducing cost and expediting development, the mechanisms for communication and collaboration across distributed labs must be effective, efficient, secure and easily deployed. Users must be able to capture and analyze data from a variety of disparate sources, manage the metadata around it, and collaborate around shared results & insights.
Scientific Computing World recently reported that software vendors are using the cloud to build secure, flexible platforms as collaborative workspaces for their pharmaceutical and CRO customers.
PerkinElmer told the magazine that organizations five years ago worried about perceived safety issues of cloud technology. Knowing the cloud has played a major part in facilitating collaborative models, we believe today the industry is far more willing, “to leverage cloud-based informatics platforms for sharing research, workflows, results and analyses.
Setting up collaborations in the cloud means that each party has access to the same informatics infrastructure. At the same time, data exchanged as part of the joint work or service activities is kept corralled in the cloud, helping to ensure that in-house systems are at much less risk of breach.”
The Collaboration Platform
PerkinElmer’s ongoing efforts to leverage the cloud are focused on providing a flexible informatics infrastructure for data sharing between pharmaceutical researchers and CRO partners. E-Notebook serves as the foundation for the collaboration platform, helping scientists take advantage of PerkinElmer’s traditional technologies (think of the rich experience delivered via the Windows client on a laptop). But now opportunities to analyze and review information are offered through a web browser. This way, users can monitor actions and submit data from mobile devices, staying better connected and improving efficiency. Helping scientists take advantage.
Data entry into analytics applications can take place not just from a single device, but the smartphones and tablets of scientists on-the-go – at conferences, in the field, even at lunch. The goal is to use technologies to get analysis results and access to data quickly, from wherever they are.
With the Collaboration Platform a pharmaceutical company can initiate a workflow request from the E-Notebook by sending requests to partner CRO using Elements. Both the sponsor and the partner collaborate and steer the work in the right direction within Elements and on completion transition the work back into the E-Notebook where it becomes part of the pharma’s knowledge base. Learn more.
These efforts will:
1. Remove the need for the sponsor to deploy a second E-Notebook or to grant access to the their E-Notebook system so it can be accessible to the CROs. Elements - SaaS accessible through a web browser- removes the IT overhead of deploying and maintaining an additional E-Notebook system
2. Enhance collaboration
• The Collaboration Platform provides better capabilities to share experimental data in distributed research environments.
• All experimental detail and results are accessible to the CRO and the sponsor company (no need to wait for results)
• The data is accessible in real time
With no indication that outsourcing will slow down, pharmaceutical companies and their CRO partners should look to the cloud – and their solution providers – for the secure, flexible informatics platforms that will enable them to collaborate, communicate, and share data in real time.
Are you living up to the promise of outsourcing? Could you benefit from a cloud-based Collaboration Platform?