Most pharmaceutical and biotechnology companies outsource some portion of their clinical development program. Traditionally, the industry has embraced the idea of outsourcing clinical trial monitoring or data management activities. More recently, vendors have begun offering software as services and providing outsourced capabilities for important activities such as electronic data capture. Simultaneously, the market for regulatory submission services providers has emerged to address the huge resource requirements of compiling and maintaining electronic regulatory submissions. Most sponsors are looking for vendors to provide specific capabilities within the clinical development continuum or the regulatory submission arena that complement their internal skill sets and Resources and align with their organizational objectives. Yet the common view of outsourcing still mirrors the functional silos that have evolved over time. In these scenarios, managers are focused on automation of specific tasks without contextual knowledge of the larger process that hinges on these tasks.
Today, effective outsourcing, whether viewed from the service or the technology perspective, requires a new approach that is much broader in scope and requires a cross-functional view of organizational bridge activities, resources, technologies and processes. This view links clinical and regulatory workflows as integrated components of the larger enterprise submission development process. It requires adjustment to traditional outsourcing approaches and also requires a shift in the types of services and solutions that outsourcing providers develop and promote.
As industry strategies for outsourcing continue to evolve, it will be important for these strategies to address “bridge activities,” those activities that result in either integration opportunities or rework scenarios between functional areas. In the clinical R&D lifecycle, the output of one functional area becomes input for another. Once data and documents are compiled within the clinical function, they are “thrown over the wall” to the regulatory function for inclusion in a regulatory submission. This simple scenario represents a significant opportunity for many organizations. Clinical data and documents will either be “submission-ready” or they will require rework to prepare them for submission to a regulatory authority. This may include reformatting of documents to enable electronic publishing, restructuring of documents to support the granularity of the electronic Common Technical Document (eCTD) submission format or manipulation of data into CDISC SDTM format. The scope and nature of the bridge activities are directly impacted by the agreements that are negotiated early in the process with the contract research organization or technology vendor. Either the deliverables will be easily included in the submission or they will require modifications in format or content for compliance with current submission standards. The latter case translates to a significant increase in time, cost and risk, particularly in the critical few weeks prior to a scheduled submission.
Bridging activities are not traditionally covered in the typical CRO contract because they are often considered “out of scope.” But if deliverables are built from the beginning as components of the regulatory submission, rework activities are limited or eliminated completely. This may require sponsors to educate their CROs on internal document and data standards or dictate that specific industry standards be used in the compilation of deliverables. For example, clinical study reports should be delivered in ICH E3 format, while data sets may be requested in CDISC SDTM format.
This emerging approach to clinical outsourcing will most often require some type of knowledge transfer to occur so that clinical resources understand submission requirements and regulatory resources understand the scope and nature of clinical activities, outsourcing service level agreements, submission standards and relevant process details. This will become even more important as industry data standards such as CDISC SDTM become an important part of the submission package. Just as process activities have developed in the context of functional silos, process knowledge has taken the same path. Cross-functional training should cover topics such as requirements for submission deliverables, industry standards, corporate standards and cross-functional processes. The outsourcing partner should be able to facilitate many of these training tasks but will require education on any corporate standards or internal processes that must be disseminated. During the transition to a more process-centric approach, sponsors may be challenged by internal turf wars and “us vs. them” mentalities. These perspectives have probably taken a long time to develop and may take a long time to overcome. It is important to collaborate with outsourcing partners to develop a strategy that provides the best external capabilities while also infusing value into internal processes through knowledge transfer. Outsourcing simply to supplement existing resources is a myopic approach that will extend minimum value to the sponsor. Outsourcing that extends integrated cross-functional capabilities while also incorporating a knowledge transfer program becomes an investment in an evolving process that will pay recurring dividends.
Resources trained in a cross-functional approach will be able to assess potential vendors, technologies and workflow strategies more accurately. These resources will also be able to design and implement new processes that reflect a broader process vision. In doing so, waste, inefficiencies and exaggerated utilization rates that result from rework loops will be eliminated. The contextual knowledge gained by participants in the process will also increase opportunities to improve the process and realize gains in efficiency. This will free up resources that can be reallocated to continuous process improvements or other knowledge-specific activities that add value to the organization.
Technology strategies should reflect this broader process approach as well. Traditional technology evaluations and implementations have been scoped based on specific functional area requirements. Often, these requirements don’t reflect downstream processes and require manual interventions late in the game. This results in an approach that requires the integration of disparate point solutions that may or may not align with the larger process goals. For example, most electronic data capture systems focus on ease of deployment and automation of data entry activities. Only a few consider how the case report forms and data are eventually incorporated into the electronic regulatory submission. This type of functionality reflects a more process-centric approach.
Technology should be a critical component of an outsourcing strategy. By outsourcing or implementing technologies that provide compliant deliverables, sponsors can avoid risk of noncompliance and decrease risk of introducing errors through manual reformatting procedures. This approach also enables the organization to align technology investments and outsourcing strategies with corporate goals and prioritize investments based on these synchronized goals.
The integration of clinical and regulatory processes will have a significant impact on outsourcing strategies. Organizational processes are not simply internal proceedings that are confined within the walls of a particular pharmaceutical or biotechnology company. Outsourcing extends capabilities by utilizing external partners. It also extends internal processes to these partners and makes them active participants. As sponsors move toward a larger process approach to outsourcing, the lines between clinical and regulatory functions begin to blur. This requires a shift in direction for most outsourcing vendors as well. Technology vendors will need to develop functionality that supports this broader process view while service providers will need to extend their expertise and merge their processes to offer more integrated offerings.
Often, the functional silos that have developed within sponsor and vendor organizations are a result of outdated, monolithic paper processes that are resource intensive and don’t add any value to the R&D process. By shifting to a more integrated, cross-functional process approach to outsourcing, organizations begin to redefine the process as a much larger, more complex, more dynamic movement. This movement will offer new efficiencies across the organization. More importantly, it will offer new agility to the organization.
Conceptually, process-centric outsourcing makes sense. But moving away from traditional tactics is easier said than done. In order to get the most out of your outsourcing dollars, it is important to get buy-in across functional lines. This means having someone with submission knowledge involved in contractual discussions with clinical vendors and having someone with knowledge of clinical deliverables involved in agreements with regulatory service providers. In most cases, functional areas will be glad to be included in these discussions once they see the potential savings in time and resources and the corresponding dollar figures.
A simple exercise that will illustrate this value in practical terms may be necessary. Select one clinical study report and supporting data and estimate the resource hours involved in authoring, reviewing and finalizing all of the components. Include time required to format and prepare and quality check the documents and data for submission. This methodology is extremely simplistic, but the number gives you a minimal cost of the information flowing through the organization. As more hands touch it, the cost goes up and the opportunity for savings becomes greater. If the contract partner can develop and deliver information in a submission-ready format that doesn’t require additional manipulation, the savings will be significant. Many sponsor organizations have struggled with these same challenges across internal functional lines. It is now time to push this methodology to global partners. Early evidence of this shift is already being reflected in the technology and service arena. Early adopters are seeking solutions that support their entire enterprise submission development process, while the vendor community is racing to develop innovative cross-functional solutions that address bridging activities and larger process issues. This is resulting in more comprehensive technology and service solutions that should lead to savings across the continuum.
Competitive research organizations drive the collection, processing, analysis, reporting and submission of critical safety and efficacy data toward the final consumers, global regulatory authorities who are responsible for reviewing marketing applications and making a determination regarding their approvability. As this end-to-end process is incorporated into outsourcing strategies, a deeper understanding of new opportunities for improvement should emerge.