Considerations when Addressing the Challenges of Time, Cost, and Data Standardization in Clinical Trials
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Clinical trials serve as the primary pre-market evaluation step for novel drugs that have made it through the time- and cost-intensive preclinical phase. Unfortunately, the traditional drug development process puts novel drug candidates at a significant disadvantage before they even make it to ...
Before starting to use the medicament or a treatment device, the biotech, pharma or medical device manufacturer launches the clinical trials –tests intended to verify the safety and effectiveness of the newly created medications – and invests in them. The aim of trials is to get an accreditatio...
Clinical trials are essential to test the safety and efficacy of new treatments in any population. The paucity of drug trials especially in the neonatal population has led to the widespread use of unlicensed or off-label medications, exposing them to the
Since it is based on the application of approved drugs to new clinical use, this alternative potentially leads to time and cost saving schemes. Additionally, information regarding clinical safety, pharmacokinetics, pharmacodynamics and potential biological targets might be easily found and assessed in ...
Food and Drug Administration (FDA)controls pharmaceuticals in the U.S., setting standards for technology in clinical trials, data integrity, and digital health applications; Health Insurance Portability and Accountability Act (HIPAA)protects patient data privacy in the U.S., influencing how technology...
Challenges that need to be overcome include ensuring equitable access, and deciding who should cover the cost of these important medical advances. CAR T-cell therapy for cancer that relapses after chemo CAR T-cell therapy wasfirst approved in 2017. InCAR T-cell therapy, the patient's own whit...
especially blood malignancies. However, clinical trials have encountered various difficulties, such as disease relapse and refractory cases. In this section, as shown in Tables2and3, the state of CAR-T cell application for the treatment of hematological malignancies is evaluated, along with its chal...
In 2009, over 17k clinical trials were newly registered worldwide. • Sponsors seek for increased operational (and cost) efficiency primary by outsourcing trials to CROs and considering new locations for research projects, e.g. CEE-based, due to constant developments in pharmaceutical industry, ...