Data Science Services at Quotient Sciences

Need rapid results to clinical data to accelerate drug development?

Faster data means we provide our customers with earlier interim data and interim PK reports for on-study dosing and formulation decisions.
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We provide rapid data to help make crucial decisions during a study

We understand that on-study changes to early phase study designs and dosing are frequent and so our study strategy for study database design and reporting is built around flexibility and rapid implementation.

  • Rapid data delivery

    Rapid data delivery

    We use eSource data collection procedures in our clinical units and a joint eSource/eCRF database.

  • Fully integrated services

    Fully integrated services

    We assign a single Project Manager for all drug product, clinical and data sciences activities.

  • CDISC member & standards

    CDISC member & standards

    When you need compliant datasets, enlist our experts that understand CDISC’s impact on early phase studies.

Leverage the expertise of Quotient Sciences, to benefit your business

Quotient Sciences

Data management & database programming

Our systems mean we can reduce data query rates, data transcription and timelines.

  • Study eSource/eCRF database set-up and maintenance
  • Study database build using Anju’s TrialOne system, a single system for collection and data management
  • Data Management Plan, data cleaning, coding, query issue and database lock
Quotient Sciences

Statistics & statistical programming

Our statistical, pharmacokinetic and scintigraphic experts understand clinical pharmacology studies and their specialized challenges.

  • Protocol input, sample size calculation and randomization
  • Statistical Analysis Plan and formal statistical analysis/interpretation
  • Program study listings, tables and figures and CDISC datasets (SDTM and ADaM)
  • Define.xml package including Reviewers Guide
Quotient Sciences

Standardizing study data with CDISC

As a CDISC Gold Member, we have built CDISC standards into all our data management and statistical procedures.

  • Develop dataset specifications and an aCRF
  • Program SDTM and ADaM datasets according to specifications
  • Provide metadata files and blankcrf.pdf
  • Include all clinical, pharmacokinetic, pharmacodynamic and scintigraphic data
  • We also offer full define.xml package

Achieve your drug program’s goals with one, integrated partner

Customer success

 
Customer Testiomonials at Quotient Sciences
“The combination of GMP manufacturing and clinical testing within one organization was, as far as we are aware, entirely unique... The understanding we have gained through working with Quotient Sciences in terms of both the formulation development and the manufacturing will be invaluable.”
Dr David Hava, Chief Scientific Officer at Pulmatrix
Customer Testiomonials at Quotient Sciences
“The company’s ability to integrate manufacturing and dosing really accelerated the conduct of the study and was one of the main reasons that Corcept Therapeutics selected Quotient Sciences to undertake the study.”
Hazel Hunt, Chief Scientific Officer at Corcept Therapeutics
Customer Testiomonials at Quotient Sciences
“Quotient Sciences’ real-time manufacturing capabilities were a key factor in determining the speed at which this study could be concluded, offering the rare combination or GMP manufacturing and clinical administration on the same site, even for complex formulations and dosage forms. This allowed us to progress much faster.”
Dr Phil Collis, Vice President of Development at BioCryst Pharmaceuticals
Customer Testiomonials at Quotient Sciences
“My first response was this is too good to be true, they can’t do that. We’ve been looking for this type of solution for years – it can’t be done. However, we made a site visit and, within three days, accepted the proposal... We had clinical data within weeks... reducing the overall timeline by half, if not more.”
Deborah Gouveia, Vice President, Program & Alliance Management at Stealth BioTherapeutics
Customer Testiomonials at Quotient Sciences
“Quotient Sciences is an honest and straight-forward company with a very progressive attitude... What makes them unique is the way in which the pharmaceutical products are made on site and transferred, without leaving the building, to the clinical unit and a good, large and reliable pool of healthy volunteers.”
Gillian C. Ivers-Read, Former Executive VP & Chief Regulatory Officer of Clovis Oncology
 
 

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