PRA understands that you want practical solutions that will efficiently and expertly improve your infrastructure to support business needs. Our Strategic Solutions offering provides a broad spectrum of solutions to meet sponsors where they are with their outsourcing needs. As the pioneer of the Embedded Solutions™ model, we have mastered the art of elegant transformation as sponsors re-align their operating model to more efficiently manage their development portfolio with greater flexibility and control . Our custom-built development solutions empower companies with limited infrastructure to leverage our extensive experience to bring innovative new approaches that enhance quality, streamline development processes and improve efficiency. Our staff augmentation solutions enable sponsors to fill gaps and maintain business continuity seamlessly. For those sponsors desiring an FSP model, we bring years of experience in this method.
THE INDUSTRY NEEDED INFRASTRUCTURE SOLUTIONS THAT WERE FLEXIBLE, AGILE AND EFFICIENT. SO WE INVENTED THEM.
01PRA is the only company in the industry to offer a strategically scalable, fully-embedded solution. The Embedded Solutions™ model is designed to merge clinical operations expertise, management, infrastructure, and support of PRA and our sponsor partner to create a cost-effective integrated outsourced operating model. The Embedded Solutions™ model minimizes the resource spiking that occurs within development programs, increasing resource utilization and significantly decreasing costs while our sponsors maintain strategic control. This global solution can include all of the service offerings of PRA and can be further enhanced by leveraging our systems and technology as required. Key Parameters of Embedded Solutions™ A Commitment to Innovation Strategic Solutions is committed to innovation and continuous improvement. Our innovation processes are designed to optimize workflow, minimize handoffs, eliminate redundancies, and shorten development timelines. We typically work with our partners to assist in redesigning existing systems and processes to drive greater efficiency, speed and quality; implementing innovative “Next” practices and enhanced technology to dramatically improve key measures of performance and provide greater cost savings.
PRA has leveraged its market leading Embedded Solutions™ expertise to provide an innovative model to bio-pharmaceutical organizations with limited/developing infrastructure. Our Custom-Built Development Solutions offer people, process, systems and expertise that enable the efficient internal development of a company’s product portfolio with greater control and flexibility, accelerated development timelines and substantially reduced costs. With your core leadership in control, we help you build the development team your company needs while enabling you to maintain the flexibility to be nimble during the development lifecycle.
The Advantages of Custom-Built Development Solutions
Custom-Built Development Solutions
Staff Augmentation Solutions
In the fast-paced environment of clinical development, sponsors must often react quickly to changes, and this often concerns finding staff to keep development moving forward. Bringing on permanent staff to fill these rolls is not always practical. PRA’s Staff Augmentation Solutions provides sponsors with the ability to address these needs while maintaining flexibility and reducing fixed costs. In order to rapidly attract and recruit qualified employees for these situations, PRA has assembled the largest personnel recruitment team in the industry. This unique infrastructure supports our ability to provide sponsors with talented individuals to supplement their internal project teams. These individual professionals are hired as PRA employees eliminating co-employment related issues to the sponsor. The sponsor has the ability to hand-select the resources according to the therapeutic and disease specific experience required. These resources can be on site at the sponsor’s facility, at PRA offices, or regionally based.
Leveraging Proprietary Recruiting Capabilities
- Largest “recruiting engines,” dedicated to research industry
- Dedicated regional and multilingual recruiting teams focused on key development functional areas
- Ability to rapidly resource, allocate and redeploy highly experienced staff
- On-going educational training ensures team knowledge of current industry standards and technologies
PRA has the ability to integrate functional services in a horizontal and/or vertical structure. This provides sponsors with the greatest flexibility when developing functional teams such as: clinical monitoring, data management, medical writing, or cross-functional teams combining multiple service areas. Our service provides dedicated capacity management within one single operating platform (e.g. sponsor systems, SOPs and processes) within one function, across multiple functions and geographies. While the sponsor provides direction and functional management, PRA provides resources and line management, training and support. We utilize business level metrics to ensure that staff are deployed with the relevant experience and are producing consistent, repeatable results, while our clinical expertise allows us to provide true clinical management across all functions or for each functional service area.
The successful launch of a new therapy is predicated upon executing a carefully designed go-to-market strategy. This plan includes a meticulously choreographed process to create concise messaging, engage thought leadership and health care providers, generate consumer enthusiasm for the product, and prepare for post-marketing commitments. When successfully executed, health care providers are provided the concise clinical and scientific information they need to maximize the impact of new therapies and/or new indications on their patients’ healthcare. Commercialization Services deploys professionals knowledgeable in launch preparation and product lifecycle management to assist clients who need to address the challenge of building their brand. These experts are skilled in a diverse set of functions and capabilities that bridge late stage development to product commercialization.
PRA Commercialization Services’ suite of appealing, creative and cost effective approaches is tailored to your company’s needs. Each of PRA’s solutions provides a cost-effective alternative to hiring the large number of resources needed to prepare launch support and manage a product’s lifecycle. Teams consisting of personnel experienced in the capabilities described below can be tailored to specific client needs as a stand-alone capability and/or integrated into the client’s existing team.
- The Embedded SolutionTM model offers an integrated outsourced operating model for contractor consolidation that provides business continuity and cost savings.
- The custom-built development solution provides the critical set of essential talent to address a client’s unique needs. Leveraging our market leading Embedded SolutionsTM expertise, we deliver an innovative model to organizations with limited/developing infrastructure.
- Staff augmentation enables our clients to handle periods of peak demand and minimize resource spiking, while decreasing fixed costs and maintaining strategic control of their commercialization activities.