Highlights from PHASTAR's Life Science Reception

Written by PHASTAR on 03 July 2019. Posted in Blog

On Thursday, June 13^th, PHASTAR hosted its first Life Science Reception in Cambridge, MA, at the Royal Sonesta hotel. Representatives from a number of leading pharmaceutical and biotech companies were in attendance.

After opening remarks from Founder and CEO Kevin Kane and Managing Director Andrew MacGarvey, Paul Stark, the Director of PHASTAR’s Boston/Cambridge office launched the evening’s technical program with a thoughtful discussion of the benefits and risks of planning interim looks at clinical trial data; that is, assessing trial outcomes before the trial is fully completed. Whether framed in a Bayesian or a classical frequentist approach, this exciting branch of adaptive trial design can dramatically reduce the duration and number of subjects required to conduct a trial but requires expert design to optimize its advantages, avoid critical pitfalls, and ensure regulatory acceptance.

Announcing the opening of PHASTAR’s European hub in Berlin

Written by PHASTAR on 24 May 2019. Posted in Blog

Beer, bratwurst, biostats! PHASTAR is delighted to announce the opening of its European hub in Berlin, Germany. The opening of this office marks an important milestone in PHASTAR’s decade long journey – as well as being our 10^th office, the Berlin office allows PHASTAR closer access to our mainland European customers, and to retain a foothold in the European market, futureproofing our award-winning service offering in the range of possible post-Brexit environment.

As part of PHASTAR’s ambitious growth plans, a huge importance has been placed on opening in new locations worldwide. We will continue focusing on attracting highly qualified, experienced staff, expanding our footprint to meet the needs of our ever-growing customer base. PHASTAR is committed to garnering new relationships with big pharma and smaller biotechs as well as further diversifying our business.

Data Visualisation: customised graphics and combining outputs

Written by PHASTAR on 24 May 2019. Posted in Blog

It has become easier to produce customised graphics in SAS and to produce reports that combine outputs from several different procedures. This means that refined outputs can be produced that allow more targeted monitoring of individual patients and populations of patients.

Customised Graphics

There is now a range of graphical elements that allow graphs in SAS to easily convey a range of information for the user to see several concepts at one time all in one picture.

PHASTAR's approach to Risk-Based Monitoring

Written by PHASTAR on 24 May 2019. Posted in Blog

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.

PHASTAR at DIA 2019

Written by PHASTAR on 24 May 2019. Posted in Blog

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.