When it comes to clinical outsourcing practices, many pharmaceutical and device teams partner with third-party solution-providers to supplement existing, in-house expertise. Contract research organizations (CROs) support clinical activities in a number of fashions. Continue reading
Earlier this summer, TransCelerate Biopharma—a non-profit life sciences group comprised of an array of industry audience types—released its most recent risk-based monitoring update. In its most-frequently asked section, the group tackles a topic that seems to be on a lot of industry executives’ minds: source data verification (SDV) in risk-based monitoring trials. Earlier TransCelerate findings indicated that conducting 100% SDV does not necessarily prevent major or critical findings. Continue reading
Contract research organizations (CROs) play an ever-present role in companies’ clinical trial practices. Many sponsors leverage these third parties to support study elements like site monitoring and patient recruitment. Patient recruitment in particular has always been a difficult task for sponsors, CROs and site teams alike. To help alleviate the challenge of patient recruitment, some CROs are customizing their approach, to ensure that they can both attract qualified study participants and keep these individuals interested throughout the clinical trial. Continue reading
Contract research organizations (CROs) can offer multiple benefits to sponsors: from helping teams to hone their internal expertise to supplementing in-house staffing and technological capabilities. Some life science teams prefer to leverage CRO partnerships when conducting clinical trials. Others may reach out to vendor parties to assist in product development well before Phase 1 studies. Still others may contract with CROs to expedite the manufacturing of active pharmaceutical ingredients (APIs). Continue reading
Third party providers often provide an invaluable resource for life sciences teams. These organizations may supplement lean in-house clinical staff and provide additional expertise, regarding patient recruitment and site selection processes. According to the Association for Clinical Research Organizations, life science companies’ use of CROs has increased by 44% from 2007 to 2011. However, according to Clinical Outsourcing: Leverage Sponsor-CRO Relationships to Accelerate Trial Timelines, a new study by Cutting Edge Information, teams may be growing increasingly selective regarding with which CROs they elect to work. A growing percentage of life sciences teams have begun leaning toward use of strategic partnerships with clinical solution providers. Continue reading
Patient recruitment isn’t just human subjects. Cutting Edge Information has conducted a number of clinically focused projects, examining an array of industry challenges. How companies recruit for their clinical trials — including what works and what doesn’t — is a hot topic for clinical stakeholders. A recent CEI study on patient recruitment highlights the percentage of companies conducting activities and who specifically —trial site, sponsor or CRO — is coordinating these activities. Continue reading
As clinical research monitoring strategy moves toward a risk-based approach, creating a dedicated team to define a risk-based monitoring (RBM) strategy and oversee the management of RBM on a per trial basis is beneficial. Dedicated risk-based management teams are able to prioritize a well-executed monitoring strategy, protecting essential elements of the trial while maximizing limited resources. Continue reading
Patient recruitment is one of the biggest challenges facing companies involved in oncology clinical development. For example, a recent study by Cutting Edge Information finds that only 43% of surveyed companies achieved planned Phase 2 oncology enrollment. Recruitment problems can greatly delay clinical trials – sometimes by as long as 20 months – and these delays cost the company and deny oncology patients much-needed treatments. If only there were some avenue through which companies could reach large communities of patients just perfect for their trials. Continue reading
When companies begin planning for national-level advisory board meetings, the first step is to delineate a clear objective and a set of goals. These stated aims will serve as useful reference points when recruiting for the meeting. They also allow for accountability — both internally for the organizers and externally for the participants — after the fact when companies look retrospectively at advisory board recruiting. The most commonly recruited ad board members are specialists in their fields, although many companies are choosing to branch out into nursing and research fields for meeting participants.
Want to learn more about Pharmaceutical Advisory Boards? Then please join Cutting Edge Information’s Lead Research Analyst Jacob Presson at CBIs “Life Sciences Advisory Board Strategy and Efficiency Summit” on April 28th in San Francisco, CA. Mr. Presson will be on hand to discuss the key points of this infographic.
With the growth in companies pipelines, clinical trial management becomes essential. One aspect of study oversight, monitoring trial risk, has evolved in recent years. In traditional clinical studies, clinical research associates (CRAs) typically visit each investigative site every four to eight weeks. However, regularly scheduled visits are fairly uniform in nature and do not always consider site experience and level of patient enrollment — factors which could potentially define a site as being either higher or lower risk. Conceivably, under this type of structure, CRAs could visit sites that hadn’t enrolled a single patient — and do so with the same frequency as sites with high patient volumes. Continue reading