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In the past, these developers mostly used in-house resources for their clinical monitoring and site management capabilities, whereas today they often prefer functional service provider (FSP) or full-service outsourcing (FSO) models, or a hybrid of the two, to ensure on-time and on-budget delivery of clinical operations.
The PPD™ clinicalresearch business of Thermo Fisher Scientific helps clients create all manner of flexible outsourcing solutions, many of which are detailed in our recent whitepaper, “Establishing a Bespoke Outsourcing Arrangement with Hybrid FSP/FSO Partnerships.”
Partnering with a CRO that emphasizes the complexity of the patient’s voice and harnesses the nuances of clinical trial design is crucial for executing successful clinicalresearch. DEXA (Dual-Energy X-ray Absorptiometry) is the optimal method for accurately measuring body composition in clinicalresearch.
For a more in-depth look at biomarkers, check out our whitepaper. Most IO Biomarkers Require Composite Use IO biomarkers can provide valuable data on a patient’s immune response to treatment and specification of which subpopulations would best benefit from immuno-oncology therapy.
The Association of American Cancer Institutes (AACI) recently published a whitepaper titled Collaboration to Develop Recommendations to Improve Trial Activation Timelines. The task force focused on three main areas of study activation: contract negotiation, budget development, and trial start up committee reviews.
For pharmaceutical innovators and drug developers working to bring oncology therapies to market, patients are the “why” behind it all. For many patients, involvement in oncology clinical trials represents a last hope for an effective therapy. Researchers often employ cell therapy studies for oncology indications, and the U.S.
Efficient and effective clinical operations are the backbone of successful clinical trials, and today’s biopharmaceutical, biotech and medical device organizations have a range of options to meet their needs in this critical area.
With many nationwide and regional lockdowns coming into force, virtual clinical trials are proving to be an effective way to monitor patients remotely. BetterLife conducts patient centric study via a fully remote clinical trial. All of these technologies can be used on a variety of devices. Source link.
Cell and gene therapies (CGTs) are one of the fastest growing areas in human therapeutics. Since chimeric antigen receptor T cell (CAR-T) therapy was first approved in 2017, there has been a marked increase of cell and gene therapy studies resulting in significant changes in the way diseases are treated as well as patient outcomes.
Covid-19 command center aims to accelerate clinicalresearch by individual sponsors to combat disease. The Covid-19 command center is customized to meet immediate needs related to research on the novel coronavirus, but can also be used more broadly for other infectious disease clinical development efforts now and in the future.”.
For a developer using an FSO model but looking to evolve the way they undertake clinical trials, a bespoke FSP/FSO hybrid solution can provide a smooth transition to FSP outsourcing. This approach enables unbroken continuity of support and resources across clinical trial operations.
Solid tumors present a significant challenge to clinicalresearch due to their complex and heterogeneous nature. Proactively Address Key Recruitment Challenges in Solid Tumor ClinicalResearch Solid tumor clinicalresearch is challenging, especially because of tumor heterogeneity.
For example, LLMs can efficiently summarize the content of clinical protocols or Investigators Brochures facilitating a more efficient writing process. LLMs are a useful tool for extracting dense information contained in whitepapers or info-rich tables, such as a schedule of assessments. LLMs assist with information extraction.
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