PHASTAR are delighted to announce the next stage in their ambitious growth plans – the opening of a new US regional office in Boston.
Already having an office in North Carolina, the opening of the Boston office will allow PHASTAR to better service the some 1,000 pharma, biotech and medical device companies in the area. It will also allow PHASTAR to access the local talent pools, continuing to attract the best statisticians, programmers and data managers to join our ever growing team.
Webinar: Tuesday, July 24, 2018 | 10am EDT (NA) / 3pm BST (UK) / 4pm CEST (EU-Central) 60 min
How do you instil quality and efficiencies into your clinical database from beginning to end? Join the webinar Efficiencies When Delivering a Quality Database, hosted by PHASTAR and Medrio, for insight into steps you can take early in your trial that will optimize your operations throughout: implementing efficient processes and establishing the parameters that best equip you to assess the quality of your database. You’ll learn how to roll out a Quality Plan template at study setup and tailor it to meet the specific needs of your study. You’ll use this plan to identify the risks and processes around the review and cleaning of all data as well as the primary efficacy endpoints based on the protocol, analysis plan and, of course, the safety data. Moreover, you’ll learn how to define and set out the acceptance criteria for each of these items, including how and when the criteria will be assessed.
Pharmacogenomics can play an important role in identifying responders and non-responders to medications, avoiding adverse events, and optimizing drug dose.
The number and range of medications already referencing pharmacogenomics can be found at Drugs@FDA, providing an extensive list of therapeutic products with pharmacogenomic information found in the drug labelling, with a few of these medications shown in the table below. The labelling for some, but not all, of the products includes specific actions to be taken based on the biomarker information.
PHASTAR recently attended the ACDM conference in Brussels. The programme was full and interesting, with plenty of scope for questions and discussion throughout the day.
There was some time spent reminiscing and reflecting, since two of the presentations covered developments in Clinical Data Management and Coding over the last 30 years. Taking the time to think back over the changes in the scale and complexity of clinical trials over that timescale, and of course the technological and regulatory advancements in our discipline, was fascinating. We learnt that coding as we know it today originated with Dr Napke in the 1970s, organising pharmacovigilance reports in pigeonholes.