Our Solutions

Customized Biostatistics Services

Altasciences Clinical Research
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Customized Biostatistics Services

Accurate, timely capture and analysis of your trial data is an important piece of your drug development program. At Altasciences, our Data Managers, Biostatisticians and Statistical Programmers partner with you to provide the quality data you need and expect. We expedite the database building process with an extensive library of CDASH-compliant CRFs/eCRFs. This allows our Data Management team to create efficiencies within the study build process, while still allowing for customization.

This methodology results in:

Cost-effective data management, Faster time to database go-live, An intuitive clinical database, Expedited database lock, Accurate and clean data

CDISC Implementation

CDISC logo

As an active Gold member of the Clinical Data Interchange Standards Consortium and a Registered Solutions Provider, we continuously review trends and changes to implementation guidelines with CDISC to assist you in the challenges of adhering to new standards. Our experts provide SDTM mapping according to current guidelines and best practices. In addition, we are proud to provide fully submission-ready CDISC packages that include the Analysis Data Reviewers Guide (ADRG) and Study Data Reviewers Guide (SDRG).

WCDASH-compliant CRFs to ensure efficient and accurate tables, figures and listings (TLFs) programming

BIOSTATISTICS SERVICES

  • Study design and endpoint development guidance
  • CRF review and collaboration with Data Management
  • Statistical consulting
  • Sample size estimations and randomization schemes
  • Statistical analysis plan (SAP) with mock TFLs
  • Data review sessions in collaboration with Data Management
  • SAS programming that is proficient with all aspects of SDTM, ADaM and TLF development
  • Statistical analyses and reports
  • Derived analysis data sets
  • CDISC-compliant data sets
  • Fully compliant submission-ready CDISC packages

No matter the scale and scope of your study, whether it’s local or international, Altasciences has the qualified team in place to bring you reliable results, fast.

Contact one of our experts today
 
Algorithme Pharma Clinical Research Vince and Associates Clinical Research Algorithme Pharma USA Clinical Research
 

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THERAPEUTIC AREAS

Our deep expertise and capabilities in a broad range of therapeutic areas encompasses preclinical and early clinical studies for both small molecules and biologics. We can manage your entire program, as well as provide support research services and bioanalytical expertise.

Please see Therapeutic Areas for a fuller discussion of our capabilities and expertise.

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