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
In todays age, many people play video games to relieve stress, solve riddles, overcome challenges, conquer opponents and plain-old have fun. But what if people could play video games as a form of medicine? Get excited, gamers of the world, because this seemingly futuristic notion may be here sooner than you think. Continue reading
The end of big pharma’s blockbuster era is often in the forefront of the industry’s strategic planning. Healthcare’s focus has long reflected pharma’s focus on products with far-reaching effects. Treatments often focus on alleviating patients common symptoms rather than targeting the specific — sometimes niche — causes of these ailments. But healthcare as a whole is changing and the pharmaceutical industry along with it. Medicine’s new focus looks past these one-size-fits-all solutions toward a more tailored treatment approach. Whereas once a blockbuster pill might have been the answer, doctors now want to fit the right (and most patient-specific) treatment to the right patient at the right time. Continue reading
One of the characteristic symptoms of schizophrenia is patients inability to differentiate among important and unimportant stimuli in their environments. Researchers attribute this symptom to a “P50 Auditory Gating deficit.” After individuals hear sounds, their cochleae typically form small electrical voltage potentials (auditory evoked potential) that are transmitted from their cochleae to their cortices. P50 represents the period from 20–70 milliseconds after patients hear a sound, but before the impulse reaches their cortices, allowing their brains to process it. When the P50 period becomes disrupted, the amplitude of the auditory message becomes reduced, making it harder for patients to process the now-quieter message. Continue reading