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European Pharmaceutical Contractor

An Evolution of Engagement

 

The sponsor-CRO relationship has traditionally been managed as nothing more than a transaction. However, with greater communication and a consideration of the technology required, both parties stand to gain from this essential partnership.

Traditionally, the biopharmaceutical industry has relied heavily on outsourcing R&D to CROs to help manage clinical trials. These partnerships between CROs and sponsors have often been managed as transactions, but both parties have much to gain from a deeper and more strategic approach. For this to happen, the CRO-sponsor engagement model must evolve to a new level, where both groups interact more effectively around mutually beneficial, businessdriven goals. In this model, CROs and sponsors would define success factors together and work to deliver long-term goals of value and innovation rather than focus solely on services, metrics, cost and quality. With the growing outsourcing trend set to continue, it is vital that pharmaceutical companies of all sizes get this process right to remain competitive and drive toward more efficient and higher-quality R&D operations (1).

Transactional Outsourcing

To date, a large volume of studies outsourced by the industry have been considered transactional engagements, in which a sponsor outsources either individual tasks or the entire management of a single clinical trial. Typically, the sponsor holds each service provider to standard metrics around individual study delivery – including speed, cost and quality. Service providers measure their own success by their ability to profitably meet the sponsors’ delivery criteria. In transactional engagements, the CRO is generally allowed to choose how they work to ensure they do not have excuses for failing to deliver results. When working with a variety of CROs in this model, sponsors must continually adapt to the

CROs’ different work processes, standard operating procedures (SOPs) and/or technologies – an inefficient way for the sponsor and associated site staff to work. Unless sponsors each standardise and use one CRO for all work outsourced, change is needed, as this current model is not able to scale with increasing outsourced business. A new focus on the combined use of strategy, technology and governance will help to achieve a more engaged, businessdriven, risk-sharing approach. The result: more efficient, high-quality and safe trial outcomes.

Go Strategic?

Sponsors have moved toward strategic outsourcing in order to solve the inefficiencies in tactical CRO outsourcing, particularly in CRO selection and contracting, clinical trial process and technology change, and reporting, data delivery and submission (2). The media has reported on many new strategic outsourcing relationships recently, including GSK with PAREXEL and PPD, Bristol-Myers Squibb with PAREXEL and ICON, and Sanofi with Covance (3). Strategic outsourcing eliminates the need for multiple rounds of request for proposals (RFPs), vendor selection and contract negotiation. Moreover, the outsourcing organisations work according to the sponsors’ SOPs, rather than dictating their own, following agreed-upon standards and formats for reporting and data delivery. The sponsor benefits from a reduction in the overheads associated with contracting with multiple outsourcers, as well as a more efficient approach to reporting and data management. CROs, in turn, can offer lower rates given the guarantee of a volume of business over a longer term. While contracts are typically set for two to three years, a few global CROs recently expressed that these contracts must be longer for both the sponsor and the CRO to achieve full benefit (4).

This outsourcing model also allows sponsors to take typical tactical outsourcing performance metrics and add metrics associated with improvements over multiple studies. From this perspective, strategic outsourcing has the potential to be a win-win for both sponsor and CRO: the sponsor guarantees a certain volume of work to the outsourcer and provides more advanced predictions of study volume, while the CRO scales to deliver the services with maximum costeffectiveness and quality.

Lost Opportunity

Despite the potential benefits, the current trend towards more strategic outsourcing still represents a huge missed opportunity to change the way the industry works with CROs and other service providers. Moving to two or three preferred partners is the first small step in outsourcing maturity that only simplifies the process and gains efficiency over time through increased elements of business trust, planning and volume. To achieve greater efficiencies, there is a need to construct a partnership driven by more mutually beneficial business goals based on clear communication, control and metrics.

Contrast pharma’s outsourcing practices with that of the manufacturing industry, which has long relied on outsourcing companies to provide various functions and components required in the manufacturing process. Their initial approach was definitely tactical, with a ‘just-in-time’ methodology dominating the industry from the 1970s to the 1990s. However, manufacturing has since moved on, as decision makers have realised that tactical ‘just-in-time’ outsourcing does not deliver optimal results. Instead, it has developed sophisticated enterprise resource planning (ERP) systems that control everything from the customer order to stock inventory and supplier management, and dispatch and invoicing. Further, these systems all deploy internet-based software-asa- service (SaaS) technology to easily provide global access to customers, outsourcers and employees. These systems have allowed the manufacturing industry to involve their outsourcers in the manufacturing process to improve planning, collaboration and resource management. Additionally, they allow suppliers to become more involved in the business goals of the manufacturer, take on elements of risk share and enjoy more rewards when goals are achieved. Outsourcing has moved to a level where the supplier is an intimate part of the standard infrastructure of the manufacturer, blurring boundaries between companies.

Similar to manufacturing ERP systems, the pharmaceutical industry has recently started deploying more integrated trial technologies that provide a platform of solutions to cover the clinical trial process. At the same time, the architecture of these eClinical solutions has moved from in-house (behind the corporate firewall and only generally accessible to internal staff ) to external, internet-based SaaS technology. The combination of these two changes provides the pharmaceutical industry with the opportunity and the tools to start rethinking the way it works with outsourcers. It also provides pharmaceutical service organisations like CROs with the opportunity to reconsider how they interact with sponsors. For those sponsors and service providers able to take advantage of this change, there is tremendous opportunity to differentiate themselves by taking these new integrated toolsets and redesigning clinical trial outsourcing processes to significantly impact the way organisations work together. This is similar to the way that the manufacturing industry underwent a revolution in the 1990s, using ERP to improve data and process visualisation across the wider organisation of tactical outsourced ‘just-in-time’ suppliers.

Clinical Trials, ERP and Outsourcing

In the world of manufacturing, ERP system processes are generally clearly defined: order processing, stock control, manufacturing, dispatch and invoicing/ finance. In this industry, the key procedure is order processing: unless orders are efficiently and accurately processed, there is little point in running the most efficient, high-quality manufacturing systems downstream. Order processing also accurately defines all resources subsequently required (stock, labour, finance and so on) – it drives the whole system.

The clinical trials process is also clearly defined: protocol design and budget planning, drug manufacture and shipment, clinical trials management, randomisation and patient data capture, safety, analysis and submission. A fairly standard functional set of clinical technologies is utilised in this process, including a clinical trial management system (CTMS), randomisation and trial supply management (RTSM), electronic data capture (EDC) and pharmacovigilance. However, the important step of automating the protocol definition process has received little to no attention to date, and yet this is the stage of clinical R&D which, like manufacturing’s order processing, defines all subsequent resource requirements for the trial processes (such as medication quantity, geographic locations, human resources, budget, analysis plan and complexity), and therefore has maximum potential impact on the outsourcing process.

Protocols are usually designed in word processing tools through a process of gathering peoples’ experience and capturing them as written words on a printed page. It is equivalent to capturing patient clinical data through the use of free text instead of today’s structured electronic case report forms (eCRF) with edit-checked boxes, drop-downs and radio-buttons. The subsequent computer capture, processing, benchmarking and reuse of the freeform text data becomes very complex and open to human interpretation; hence, subsequent management processes often become inefficient.

Designing and building studies in a structured SaaS protocol authoring tool that is securely and easily accessible across the internet can change the process of protocol design, enabling a transformation of the outsourcing process. CROs can be intimately involved with or responsible for this key step – capturing their expertise in the therapeutic area under investigation – while the sponsor can actively observe and contribute to the whole process.

With protocol information defined in a structured tool, there is opportunity for huge efficiency improvement, similar to the manufacturing ERP system in which order details are accurately and efficiently passed to the dispatching and invoicing processes. The structured trial protocol design can easily be exported in computerreadable format to downstream eClinical systems, enabling the accurate definition of the eCRF, electronic patient reported outcome (ePRO) or CTMS designs. This can improve the efficiency of subsequent trial processes, shorten timelines and mitigate risk of subsequent data quality issues and study amendments.

Finally, the structured protocol provides inputs necessary to accurately define resources required for the clinical trial. This is particularly beneficial in a strategic outsourcing relationship involving multiple trials or clinical programmes. The CRO can now obtain a much better idea of the resources required to fulfil the needs of the sponsor and obtain insight into this information much earlier in the process. This enables the service provider to accurately and efficiently scale resources to provide optimal cost management throughout the duration of the trial.

Sharing Data

There are a few other requirements for a clinical trial ERP system to succeed. The industry has quickly caught on to the benefits of SaaS technology and many SaaS-based eClincial solutions are now available. Each individual SaaS solution brings advantages to site, CRO and sponsor, but while the focus to date has been on the advantages of individual applications – typically faster deployment and productivity, streamlined use and management, increased flexibility and scalability, and better reliability and performance – little has been made of the fact that SaaS applications provide a secure mechanism for multiple organisations around the world to share access to common data and information. This offers tremendous potential within the strategic global outsourcing business if the following guidelines are closely followed:

Technology Choice

Pharmaceutical companies must care about technology choice. Traditionally, the pharmaceutical industry has left technology choice to its outsourcing organisations. Whether tactical or strategic, if each of the sponsors’ service providers uses different technologies, opportunities for efficiency gains will be missed. For best results, the pharmaceutical organisation should standardise on SaaS applications that best support their outsourced activities and can be integrated to enable reuse of structured protocol definition data.

Structured Protocol Authoring Tools

Clinical trials benefit greatly from structured protocol authoring tools. Significant change can be driven through the tight integration of sponsors and service providers around a common SaaS-based protocol authoring tool. Increased risk sharing and all downstream processes benefit from adopting such technologies within a strategic outsourcing relationship, although even transactional engagements can see benefits from this technology.

Encouraging a Common Process

Using a common technology is no guarantee of common processes, standards or workflow. The technology choice needs to be supported by a SaaS outsourcing deployment framework (governance), especially before deploying to multiple CROs. Global library standards, common elements of look and feel, workflow processes and data standards can all impact the efficiencies of those using the applications – sites, clinical monitors, data managers and statisticians, as well as managers reporting on study progress, financials and so on.

An Integrated Approach

The industry must think about an integrated approach to clinical trials, as opposed to individual SaaS technologies as point solutions. Significant efficiency and quality gains are achieved through a holistic approach to integrating solutions and processes across different technology suppliers, or by integrating SaaS technologies with key in-house solutions to define a clinical trials’ ERP environment that suits the organisation. Standard integrations using open Clinical Data Interchange Standards Consortium (CDISC) and web services standards (Simple Object Access Protocol (SOAP)) are essential. Once data is entered in SaaS technology it should not need to be reentered into another system.

Both organisations should think outside of the box when deploying SaaS solutions. In tactical outsourcing, the sponsor will design the protocol; the CRO will negotiate the site budgets, control the site contracts, build the electronic client report form (eCRF), and so forth. SaaS solutions enable workflow within a task across different and remote people and organisations. This mix of workflow and expertise across organisations can dramatically reduce study costs, avoid high dropout rates/non-evaluable patients, increase patient safety and improve the opportunities for a rapid and successful final study submission.

This is an exciting time for sponsors and CROs to redefine industry partnerships. Widely available SaaS eClinical solutions now provide the means to improve clinical trial design and conduct, from start to finish. Clinical trial ERP systems can now be securely accessed from internal and outsourced staff resources, providing improved data visibility, feeding downstream eClincial systems and reducing, or even removing, the need for re-entry, incorrect interpretation and quality issues. With this blueprint, the time is right for pharmaceutical outsourcing relationships to significantly evolve.

References

  1. Tsai Z, Mergers and Alliances, 2010
  2. Taylor N, Strategic deals drive market share deals for big CROs, Outsourcing Pharma, 20 April, 2011
  3. Macdonald G, GSK selects Parexel and PPD as strategic CROs, Outsourcing Pharma, 21 September, 2010
  4. Taylor N, ICON seeks longer partnerships to avoid 3 year deal probs, Outsourcing Pharma, 21 March, 2012

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Graham Bunn is Vice President of Partnerships and Alliances at Medidata Solutions. As an early pioneer of EDC technologies, Graham brings more than 20 years of experience in the pharmaceutical industry. At Medidata Solutions, Graham coordinates and manages relationships with various CROs, systems integrators and other services organisations. Graham is a member of the Electronic Data Management Forum and the Drug Information Association (DIA) and has been actively involved in the CDISC organising committee in Europe. He has also written widely on the successful deployment of clinical development technology and pharmaceutical outsourcing.

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