Email communications with business stakeholders in the healthcare industry are critical due to stringent regulatory timelines that mandate specific compliance requirements. At the same time, managing information security amidst an ever-evolving threat landscape is...
As family members and caregivers, it is a fundamental human instinct to do everything possible for the cancer patients in our lives. These moments challenge and define us. We leave no stone unturned in providing comfort and seeking out the best care and, in doing so,...
Clinical study protocols serve as the foundation for conducting medical research and are critical for drug development and approval.To ensure compliance with subject protection standards and statutory requirements, clinical study protocols are submitted to global...
Biotechnology-derived pharmaceuticals (biopharmaceuticals) cover a broad variety of active substances, including proteins and peptides, their derivatives, and products composed by proteins and peptides, that could be developed from cell cultures or using recombinant...
In today's digital age, data privacy and protection have become paramount concerns for organizations across various industries. Last year alone, the HIPAA Journal reported that a record-breaking 133 million individuals had their healthcare data compromised across 655...
For many professionals in the clinical trial planning and execution phases of drug development, the quality control (QC) function is often considered to operate only to ensure the quality of documents prepared by Medical Writing. This is especially important, as the...
The PSI 2024 Conference at Beurs van Berlage in Amsterdam, The Netherlands brought statisticians and leaders in the pharmaceutical industry together from across the globe. The energy was invigorating and great conversations were the norm, among the hundreds of...
Chemistry, Manufacturing and Controls (CMC) is an integral aspect of any drug candidate development and is critical for ensuring protection of the clinical trial subjects. CMC includes information such as the physiochemical or biological properties of a molecule, its...
The Oncology Center of Excellence (OCE) Real-time Oncology review (RTOR) Pilot program was initiated in February 2018, specifically for supplemental oncology new drug applications (NDA)s and biologic license applications (BLAs) of previously approved drug products....