Data quality and integrity are key aspects of Good Clinical Practice (GCP) and sponsors are expected by regulators to demonstrate oversight of clinical studies to ensure proper conduct, safety of study subjects and accuracy and completeness of the clinical study data. Risk Based Monitoring is an approach that aims to implement improved and more efficient approaches to clinical trial design, conduct, oversight, recording, and reporting, while continuing to ensure human subject protection and reliability of trial results.
Oversight of a clinical study has traditionally included on-site data monitoring and performing Source Data Verification (SDV), i.e. confirming that the data in the CRF accurately reflects the source notes.
The PHASTAR team is excited to announce our attendance of DIA 2019 Global Annual Conference, which takes place from June 23rd – 27th at 111 W Harbor Drive San Diego, CA.
Our team can be found at booth 1854. Our CEO, Managing Director and technical team will be attending so be sure to visit our booth to hear about PHASTAR and our capabilities.
The PHASTAR team is excited to announce our attendance of the 2019 BIO International Conference, taking place from June 3rd – 6th at the Pennsylvania Convention Center: 1101 Arch St, Philadelphia.
PHASTAR are also proud to be sponsors of the inaugural C14 Foundation’s* Annual Charity Gala on Wednesday, June 5, 2019. The gala will raise money for a number of charities including St Jude’s Clinic in Haiti and the Soilless Agriculture Project in India.
Understandably, there is considerable excitement around the field of data science particularly in relation to healthcare and clinical trials. As described in another article in this newsletter “Machine Learning”, a key area of data science, is rapidly gaining traction in the healthcare industry.
At PHASTAR, the demand for data science led services has been increasing over the past few years, with many of our customers asking us to help them as they explore artificial intelligence, machine learning, and complex analytics. Data science is a multi-disciplinary field, bringing together different computational and mathematical/statistical skills with a wealth of experience in clinical trials and healthcare. There is considerable overlap between the field of data science and statistics and here at PHASTAR we have a strong and successful reputation for our statistical expertise.