Quality data, real world findings and meaningful outcomes
Accelagen delivers high quality Biostatistics and Data Management services that prioritise quality outcomes and regulatory requirements.
Our in-house capabilities ensure a streamlined process to record, analyse and report on trial data comprehensively. We develop tailored data management solutions to meet your needs in line with the Clinical Data Interchange Standards Consortuim’s (CDISC) ‘best in class’ specifications that enables the accessibility, interoperability, and reusability of data that meets the ever increasing regulatory standards.
Data Management
- CDASH compliant Database / Case Report Form design and development by In-house Database designers
- CRF data review and data query status reporting with metrics
- Data cleaning and medical coding of clinical data, adverse events and medications using gold standard libraries
- Management of laboratory vendors, including data transfer specifications
- Study Randomisation and Trial Supply integrations
Biostatistics
- Strategic consultation of clinical study design, protocol development
- Leadership in novel study structures, including adaptive design
- Randomisation support and programming
- Development Statistical Analysis Plans and Reporting
- Creation of custom data outputs to support DSMB meetings, interim analyses, futility assessments
- Interim and Final Data Analysis and contribution to Clinical Study Report or Manuscripts by In-house Experts
- Regulatory submission ready outputs: CDISC model SDTM and ADaM datasets, define.xml documents, Reviewer’s Guides, with Pinnacle 21 validation
- Utilisation of gold standard technology solutions, including WinNonlin and SAS
How we work
Planning for quality outcomes
We design protocols, investigative and statistical analysis strategies with a focus on real world findings.
Globally compliant approach
Research that meets international requirements and has outcomes that are transferable across markets.
Trial designs to fit your needs
Our expertise includes randomised controlled, parallel group, crossover, adaptive, retrospective and prospective.
Fit-for-purpose datasets and databases
Keeping data secure, meeting best practice standards, and rigorous quality assurance to maintain the integrity of study outputs.
.svg){kind=icon}
The right systems to support your study
Our data and inventory management solutions are world-class and integrate seamlessly with your internal systems.
Meaningful and customised reporting
We build reports that arm you with the right information for data reviews, interim analyses and monitoring committees.
Biostatistics and data management
case studies
.webp)
