CLINICAL STUDY REPORTING

PHASTAR has a unique approach to the analysis and reporting of clinical trials. All our staff are trained in "The PHASTAR Discipline" - our in-house philosophy relating to the methodology of clinical trial data analysis and reporting.

PHASTAR has experience in all therapeutic areas, including:

Oncology
Rheumatoid Arthritis
Asthma, COPD and Respiratory Diseases
Vaccines
Pain, Headache, Migraine
Metabolic Disorders (e.g. Diabetes, Lipids)

Haematology
Cardiovascular
Gastro-Intestinal
Anti-Infectives
Dermatology
Neurological Disorders (e.g. Depression, Epilepsy, MS)

Opthalmology
Medical Devices
Rare Diseases
Immunology
Antiviral
CNS

We cover all phases including the following types of studies:

Adaptive designs
Crossover and parallel group
Drug interaction
Absolute and relative bioequivalence

SAD/MAD
Food effect
Meta-analyses and Integrated datasets
Observational

Radiotracer
Superiority, equivalence and non-inferiority
Single dose and steady state
Special populations e.g. renal and liver impairment studies

Our services include:

Reporting of phase I-IV trials
Integrated summaries of efficacy and safety
Conversion of legacy data to CDISC standards
Creation of SDTM and ADaM datasets

Define.xml and/or define.pdf
Meta-analyses and Integrated datasets
Observational and real-world evidence studies
CDISC compliant documentation

Annotated CRFs
Superiority, equivalence and non-inferiority
Clinical pharmacology studies (e.g. drug interaction, bioequivalence, radiotracer, food effect, special populations, renal and liver impairment studies)

CDISC

PHASTAR's Programming team provide expert CDISC services as well as the development of dataset specifications. If you have a submission approaching with legacy format datasets, PHASTAR can upgrade these to CDISC compliant datasets (SDTM and ADaM). PHASTAR’s senior team has extensive experience with regulatory bodies and participate in regular regulatory interactions.

We can provide all the necessary associated documentation that a submission to the FDA will require (or other global regulators), including annotated CRFs, define.xml and/or define.pdf and a regulatory reviewer's guide. If you are planning an integrated summary of efficacy and safety, we can help put together CDISC compliant datasets. We can also provide advice on the format of the data that will be acceptable to global regulatory bodies.

Read our case study

What our clients say

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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