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Clinical Trial helping Hands

Serving the Pharmaceutical,
Bio-Medical, Healthcare Industries
with the Safety and Efficacy.

Quality is the highest priority
With a multiple validation methods

Clinical Trial helping Hands

Serving the Pharmaceutical,
Bio-Medical, Healthcare Industries
with the Safety and Efficacy.

Quality is the highest priority
With a multiple validation methods
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About Us

We Are Providing
Best Service Since
2001 to present

VClinical Biostats is a global Contract Research Organization (CRO) based out of Austin, Texas and India that aims to provide Clinical SAS programming support. VClinical Biostats specializes in clinical data standardization for Phase I through IV Clinical Trials and is also involved in other regulatory services related to pharmaceutical product development. VClinical Biostats's strong beliefs and values define what we stand for and determine how we work. We have all the resources needed to analyze data obtained from Phase I through Phase IV clinical trials. Our expertise encompasses understanding the design of the protocol, recruiting patients effectively, managing the entire regulatory approval process efficiently, and making timely deliverables without constraining the client’s budget. Additionally, we stay up to date with rapid developments in the corporate arena and continuously review and upgrade ourselves to address these changes in the most effective manner.

Our Services

ISS/ISE

We provide support for the integrated summaries of safety and integrated summaries of efficacy data prior to regulatory approval.

Meta Analysis

Our expert statisticians can advise on potentials for bias during a Meta Analysis as well as on statistical methods to use.

Clinical Data Interchange Standards Consortium (CDISC)

Using CDISC standards ensures that the data used in the outputs produced complies with regulatory standards.

Output Production

Using your systems or Quanticate's standard macros with SAS ® Programming and R Programming ensures increased efficiency when producing study report outputs.

PK/PD Analysis

Non-compartmental analysis using Phoenix WinNonlin® and statistical analysis with the relationship between exposure and response modeled using non-linear models and the use of non-linear mixed effect modeling.

Production of Statistical Reports/Statistical Review of Clinical Study Reports (CSRs)

Non-compartmental analysis Our statistical and medical writing teams collaborate to produce high-quality reports which display the study reporting results of trials. These are then used by Medical Writing in the creation of CSRs. We also review these CSRs from a statistical perspective to ensure statistical integrity is upheld.

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