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The industry source for pharmacokinetic and biostatistical services.


Biostudy Solutions

a pharmacokinetic and biostatistical consulting firm

Their staff has worked with hundreds of companies, helping them advance their generic and new drug submissions to U.S. and foreign regulatory authorities. A depth of experience – combined with a vast partner network within the industry – allows BSS to provide complete solutions to statistical and report preparation needs.

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Chris Matheus
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Denise McNereny
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Pharmacokinetic/Biostatistical Consulting

Biostudy Solutions works with the client throughout their product development process.

  • Protocol development
  • Research and design
  • Level C IV/IVC evaluations
  • PK/Statistical analyses for BA/BE studies (complete or confirmatory)
VCA Study Support

Biostudy Solutions provides its clients the service they need for demonstrating bioequivalence of topical corticosteroids.

  • Design of VCA trial
  • Dose response modeling and interpretation
  • Bioequivalence evaluations
Stability Trending

Biostudy Solutions provides its clients with support from specification determination through stability expiration dating.

  • Exploratory analyses to assist in determining specifications that support the data
  • Stability trend analysis and expiration dating
Report Preparation

From receipt of data to completion of Module 5.3, Biostudy Solutions offers its clients an effective, cost-efficient, approach to the backend services of a trial.

  • Report compilation for BA/BE studies (ICH compliant)
  • eCTD Publishing

Get your time back and let us find the solutions you need!

GLSA’s Global Network of solutions incorporates a variety of CROs and specialty vendors to support the specific needs of your clinical trial. Our network includes full-service CROs, biometrics, site selection, patient recruitment and retention, clinical supply chain management, and more. GLSA pre-qualifies all members of our network so you can be comfortable working with quality service providers.

We connect Sponsors with the CRO that has the right experience, culture, and capabilities to execute their research protocol. We leverage our extensive experience and harness our key relationships to work for CROs. We can fill any gaps you need to support your client’s trials. GLSA takes the guesswork out of vendor selection with our industry experts and experience.

What are your challenges? Contact GLSA to learn more about how we can help you accelerate your speed to market.