Pharmaceutical Clinical Research Associates (CRAs) are critical members of the drug development team responsible for managing and monitoring clinical trials that test new medications for safety and efficacy. They ensure that trials are conducted in compliance with regulatory standards such as Good Clinical Practice (GCP) and study protocols. CRAs regularly visit clinical trial sites to verify the accuracy of collected data, confirm that patients meet eligibility criteria, and ensure informed consent has been properly obtained. By meticulously reviewing case report forms against source documents, they help maintain data integrity and protect patient safety throughout the study. Their monitoring activities are essential to producing reliable and valid results for regulatory review.
In addition to site monitoring, CRAs serve as a communication link between pharmaceutical sponsors, clinical investigators, and regulatory authorities. They provide ongoing support and training to clinical site personnel to uphold quality standards and regulatory compliance. CRAs also prepare monitoring visit reports and assist in the preparation of documentation required for audits and inspections. Strong attention to detail, excellent organizational skills, and the ability to manage multiple sites are crucial attributes for success in this role. Ultimately, CRAs help ensure that clinical trials are conducted ethically and efficiently, contributing to the development of new therapies that improve patient outcomes globally.
Title : Ectopically expressed olfactory receptors as an untapped family of drug targets and discovery of agonists and antagonists of OR51E1, an understudied G protein-coupled receptor
Vladlen Slepak, University of Miami Miller School of Medicine, United States
Title : Managing healthcare transformation towards personalized, preventive, predictive, participative precision medicine ecosystems
Bernd Blobel, University of Regensburg, Germany
Title : Analytical strategies for solid-state forms in drug development
Maria Cristina Gamberini, University of Modena e Reggio Emilia, Italy
Title : Understanding drug transport in plasma: The role of protein binding
Saad Tayyab, UCSI University, Malaysia
Title : Innovative development and delivery of biologics for chronic obstructive pulmonary disease
Yong Xiao Wang, Albany Medical College, United States
Title : Search for novel biomarkers and therapeutic targets for inflammatory disease
Madhav Bhatia, University of Otago, New Zealand
Title : Personalized and Precision Medicine (PPM) as a unique healthcare model through de-sign-inspired biotech- & biopharma-driven applications and upgraded business mar-keting to secure the human healthcare and biosafety
Sergey Suchkov, N.D. Zelinskii Institute for Organic Chemistry of the Russian Academy of Sciences & InMedStar, Russian Federation
Title : Design and evaluation of exo-itc: A bilayer fibrous system for controlled exosome delivery in dermatological applications
Luis Jesus Villarreal Gomez, FCITEC - Universidad AutĂłnoma de Baja California, Mexico
Title : Abuse-deterrent dosage form technique utilizing a fusion of innovative pharmaceuticals and ion exchange resin
Bhupendra Gopalbhai Prajapati, Parul University, India
Title : Macitentan/tadalafil combination– An additional value in pharmacotherapy of pulmonary arterial hypertension
Miroslav Radenkovic, University of Belgrade, Serbia