DATA MANAGEMENT

Our experienced team of Data Managers are on-hand to advise and support all aspects of data capture and analysis from CRF design through to database lock. We have extensive experience in all phases of trials and work closely with both the clinical and reporting teams to ensure efficient collection and delivery of the highest quality data.

We have knowledge and expertise across a wide range of software solutions and we partner with a variety of data management platforms in order to best support our clients' individual needs. PHASTAR's accreditation status with Medidata enables us to deploy cutting-edge tools from the Medidata Rave Clinical CloudTM including Rave EDC, Coder, eCOA, and RTSM. Additionally, PHASTAR is part of Medrio's Partner Program. Medrio's integrated eClinical software platform and fully hosted EDC system offers small to mid-size BioPharma simple, fast, and affordable solutions for the collection and management of clinical data.

Our software partners

PHASTAR is a Meidata Partner, accredited to offer services on Medidata Rave EDC

Our services include:

Cross-functional biometrics team plans
EDC, including accredited Medidata Rave support
Paper CRF and hybrid options also available
Risk-based monitoring
IWRS
CDASH standard datasets
Database build and validation
Data entry

Extensive edit checking
Clinical Team and Site training, mentoring and support with EDC
Site metrics for CRF completion and Query Resolution
Continual Quality Control review including audit trail logging
MedDRA and WHODrug coding
AMP, cell therapy studies, Observational, Device and Marketing studies
3rd party vendor oversight and data transfer planning

Data Management Oversight

PHASTAR was engaged to conduct oversight of data management activities on behalf of one of our established clients, a large pharmaceutical company...

Big Pharma Company

“We have now reviewed the Subgroup analysis and have no comments. The Team has asked me to say " A huge thanks to the team!!! :)" on their behalf! Thank you again for all your hard work and effort to deliver this project.”

Mid-Size Biotech Company

“Thanks for sending these through, and ahead of schedule; fantastic work!”

Top 20 Pharma Company

“I just wanted to personally thank you for your support on the post-hoc analysis for the study during. I think it is great testament to your desire and ability, that you were able to conduct these requests so quickly, and the team really appreciated it “.

Top 10 Pharma Company

The Global Stats Lead said, “she wishes she could work with PHASTAR staff on all her projects if she could”. That was just one of several positive comments we heard about PHASTAR staff during our recent face to face meeting with their senior managers/Biostats head.

Top 10 Pharma Company

“I just wanted to say a big Thank You for delivering this to us according to the agreed timelines. Can you please pass on my sincere thanks to everyone at Phastar who worked on this as I realise everyone will have played their part in this important deliverable. Having gone through all the outputs it is evident there is a huge number of outputs that have been produced particularly when we add in the extras needed for the certain subgroups. Hence, I am very pleased you have managed to produce all of this to time.”

Large Pharma Company

“This week it happened – request number 2000 was finalized. I would like to take the opportunity to thank all of you for achieving this huge number. I know it wasn’t always easy (timelines, amount of outputs, etc.), but you did everything to achieve even the impossible. So congratulations to all of you”.

Top 10 Pharma Company

The vendor faced a challenging situation as they took over this complex large study at a very late stage, Phastar have delivered to great quality and have enabled us to maintain the PSC timelines. We have many challenges still to come but with performance like this I have optimism that we will have a successful PSC.

Top 10 Pharma Company

“The data quality (both SDTM & ADaM) is very high and deserves the high rating. Phastar has, despite challenging timelines and a complex study, delivered high quality data. Really good job.”

Top 10 Pharma Company

“Phastar has once again delivered a high quality BDR according to agreed timelines despite challenging timelines. Phastar has resolved and incorporated all the comments from previous BDR and we believe that we have great opportunities to have a successful BDR.”

Top 10 Pharma Company

“Thanks you so much for all your hard work and dedication to meeting the very tough timeline, to make this delivery. It is very much appreciated.”

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