Clinical Outsourcing

Leverage Sponsor-CRO Relationships to Accelerate Trial Timelines

Clinical Outsourcing

$3,495.00

Dive into the experiences of trial stakeholders — including sponsors, CROs and site teams — in trial planning and execution. Findings focus on two critical components of trial success, site selection and patient recruitment, while also examining critical metrics, including trial staffing, costs, timelines and challenges. Use this information to better plan for challenges, including issues around patient enrollment and key trial milestones. At the same time, strengthen the CRO-sponsor relationship to share risk and increase communication, improve coordination across multiple vendors and implement innovative strategies.

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Report Details

Prepare your trial for success with the right vendor relationships and proper patient recruitment strategies. Patient recruitment rates among top challenges for clinical trials, and vendor selection can have a huge impact. Companies that consider recruitment obstacles concurrently with protocol design, look outside of clinical practices to reach enrollment quotes, and involve vendors early better align their organizations for trial success. This report addresses the resources and best practices necessary to facilitate desirable recruitment outcomes. In addition,Clinical Outsourcing examines new patient recruitment strategies, including the use of EHRs and social media.

Publication Date: June 2015
Pages: 316
Number of Companies: 60+
Chapters: 5
Metric:s 500+
Charts/Graphics: 280+

Report Features

For companies outsourcing any aspect of a clinical trial, selecting the right vendor and effectively communicating sponsor needs are pivotal to success. Strategic alliances work well for companies that constantly conduct clinical trials. However, they are not always feasible, especially for smaller companies with fewer resources. Examine the relationships between sponsors and CROs, including the types of vendors employed, selection criteria and best practices for maintaining successful relationships. This report examines the relative value of strategic alliances with both CROs and research sites. Alliances are not always possible, and some executives are skeptical of the practice. As CROs become more involved in clinical trial planning — a trend projected to occur over the next three to five years — this attitude will shift.

Reason to Buy

Carefully consider site selection when mapping out clinical trials. Site selection and site monitoring are key components of clinical trials. As such, companies should consider site background and operations prior to enrolling patients to ensure that a location will fit trial needs. In addition, retaining a small percent of clinical site monitoring staffing in-house will help build internal expertise, ensure site visit consistency, and ultimately make sure that trial progress stays on track. The report explores sponsor and CRO site selection criteria and site management challenges. Use the benchmarks and best practices to strengthen communication and cultivate consistency in monitoring efforts.

Target Audience

The target audience for this study includes clinical development and operations vice presidents, directors and managers. Clinical trial management teams who work with vendors to determine site selection, patient recruitment and protocol development will also benefit from the best practices and benchmarks in this study.

Chapter Example

Life science companies involve a number of in-house clinical groups to facilitate their ongoing medical trials. When in-house teams are not enough, companies may seek the added expertise of either general or specialized contract research organizations (CROs) to support their studies. Large pharmaceutical companies may work with large CROs as part of a strategic alliance. A recent CenterWatch study estimated that among the Top 10 CROs, 71% of revenue comes from a mixture of functional service — or clinical activities such as monitoring and data management that are performed outside the scope of a long-term agreement — and integrated alliances. Smaller companies may prefer to leverage CRO expertise on a case-by-case or transactional basis. Likewise, mid-sized and niche CROs report that higher percentages of their earnings — 60% — result from transactional relationships with pharma and device companies.

CROs may assist sponsors with both trial design and execution components. Increasingly, surveyed teams anticipate transitioning some of their trial planning responsibilities to experienced CROs. During the planning phase, CROs may leverage their experience with specific therapeutic areas or regions to help teams plan out a feasible trial methodology. Once trials are underway, they may assist companies with operational trial components, from patient recruitment to site monitoring.