As we enter the 2019 labeling landscape—with changing regulations and slashed submission timelines—producing labels with 100% accuracy is proving to be increasingly complex and load-bearing for clinical supply teams. In the months to come, here are a few key topics that we are keeping an eye on.
Dr. Joan Meyer, Covance Executive Director of Strategy & Planning for Inflammation, Infectious Diseases and General Medicine, discusses her team’s efforts to better understand patients’ opinions about inflammatory bowel disease trials and develop patient-centered clinical strategies to improve study recruitment.
A large pharmaceutical company asked Covance to support their studies for a diabetes Phase III program specifically to register a drug to treat Type 2 Diabetes. Read how Covance utilized its rich central laboratory services database and helped the sponsor achieve first patient in (FPI) ahead of schedule for all studies in the program and beat historical industry performance across a number of key metrics.
An emerging biopharmaceutical company was designing a Phase II trial in patients who had Type 2 Diabetes, Stage 3 chronic kidney disease (CKD) and macroalbuminuria. They were uncertain about how to balance the selection of the right patients for their trial endpoints with the ability to achieve rapid subject recruitment. Read how LabCorp de-identified clinical laboratory data helped evaluate the protocol feasibility and the overall design of the study while also making an adjustment in eligibility criteria was forecast to double the eligible patient pool – without impacting study endpoints.
Discover how Almac helped one pharmaceutical company streamline processes and remove risk from their multiple clinical trial applications while maintaining data integrity with One Unified Clinical Trial Supply Solution.
Whatever your goal may be, online marketing can be integrated into your strategy to help make recruitment a success this fall. Read on to learn how social media and text messaging programs can help support your traditional recruitment campaigns.
Software implementation does not have to be a scary proposition. In this video, implementation experts – with a 100% success rate – discusses what works and why.
For sponsors, it can be frustrating trying to recruit participants for clinical trials. For patients, trying to find a clinical trial can be equally frustrating. See patients and caregivers reactions when they are shown the easy to understand and navigate website powered by TrialScope Engage.
Dr. Jack Modell discusses why there is more to the story than placebo response in regards to the high failure rate of clinical studies in depression. Identify other factors that can contribute to failures and what steps can be taken to avoid those pitfalls.
While we can’t predict the outcome, planning ahead for appropriate site and subject selection will take you one step closer to ensuring the successful conduct of a study. From study design to logistics to recruitment, this webinar will look at the key differences between studies conducted in pediatric populations and studies conducted in adult populations.
This webinar will explore the rationale for implementing patient-centered practices and offer guidance for initiating patient-centered approaches to research. Review practical strategies for engaging patients in the clinical trial process without sacrificing research quality or adding untenable costs to your trials and understand which factors matter to patients and how to design trials that honor their needs and desires.
Whether indications of fraud appear as missing documentation, altered numbers, signatures that don’t match, or unavailable medical records Clinical research associates (CRAs) must be aware of the many signs of possible fraud or fabricated data occurring at a clinical trial site. This webinar explains the signs to look for and the proper protocol to handle and report the misconduct during each monitoring visit.
Almac’s One Unified Clinical Trial Supply Solution has one objective to guarantee the study drug is with the patient at the right time while ensuring the complete chain of custody and minimising wastage of drug from production to destruction.
Up to 60% of clinical development time and 40% of cost are spent on patient recruitment. Data can help, but simply accessing more data only muddies your decision making. With Covance, you get the right analysis on the right data to empower your studies. Recruit eligible patients that fit your protocol faster, identify and secure proven and/or new sites, forecast and measure progress more efficiently. With Covance’s proprietary data, your program hits its mark.
In order to demonstrate a deeper commitment to clinical trial transparency than the law requires, some sponsors are choosing to provide additional information about their portfolio of clinical trials on a dedicated website. TrialScope Engage can help sponsors manage clinical trial content that is being prepared for disclosure on their own sites.