We are able to take a step back and understand your challenges. Our team ensures that your studies are appropriately designed, that data quality and integrity are optimized, the results are robust and correctly interpreted, and the findings are accurate, precise and properly reported.
We offer a range of biostatistical services to assist our clients and support clinical studies across various phases and therapeutic areas.
- study design: fixed or adaptive design, sample size, power computation, statistical methodology and randomization methods for study protocols
- statistical analyses: statistical analysis plan, including plans for pooled and integrated summaries, statistical programming, production and validation of tables, figures and listings
- reporting: interpretation and guidance for significance of results, and input into study reports, manuscripts and presentations
- data monitoring: independent statistical oversight for study independent data monitoring committees and data safety monitoring boards
- regulatory submissions: creation of data submission packages meeting regulatory requirements, critical statistical review of submission documents, participation in meetings, and providing input into responses to regulatory authorities
Our Clinical Data Management services are tailored to study-specific needs, to deliver the highest level of data quality and integrity, while improving efficiency, shortening timelines and reducing risks. Our end-to-end Data Management solutions include:
- study set-up: eCRF and ePRO/eCOA design and maintenance, creation of Data Management Plans and other specification documents
- study conduct: data cleaning, medical coding, integration and reconciliation of external data, online and offline customized reporting (metrics, trackers, listings), and management of protocol deviations
- study closure: data review meetings, interim/final database lock, production of datasets in CDISC SDTM format, and Data Management reporting
Our team provides expertise in the following areas:
- methodology in clinical research, epidemiology, outcomes research and pharmaco-economics: evidence synthesis (meta-analyses, direct and indirect comparisons), healthcare database analyses, safety signal detection, questionnaire psychometric properties, exploratory analyses, data mining and statistical modelling
- technical support: randomization list generation, data mapping and pooling (including CDISC SDTM/ADaM standards and associated submission packages), results validation (reprogramming), medical coding (WHODrug, MedDRA), risk-based approach
- project management: coordination and follow-up of data management, biostatistics and medical writing activities, review of associated deliverables
Electronic Data Capture system: Viedoc™
We were one of the early adopters of Viedoc™ 4 in 2016 and maintain a privileged relationship with Viedoc technical and commercial teams.
Our clients particularly appreciate:
- an optimized set-up time and maximal ease of use
- a modern and streamlined interface, to efficiently access, manage, review, and share clinical trial data
- a complete and modular solution: EDC, ePRO/eCOA, randomization and trial supply management, reporting tools, eTMF
- regulatory compliance with health authorities requirements
- our extensive experience and knowledge of the Viedoc system in all types of studies
Our medical writing services involve the preparation of various documents related to the conduct of a clinical study, including study protocols, informed consent forms, Investigator Brochures, clinical study reports, regulatory documents, lay summaries, and manuscripts for publication. We work with medical writers who are trained in the scientific and regulatory aspects of clinical studies. Together with the study team, they ensure that the results are accurately and effectively communicated, and that the study is properly documented and meets regulatory requirements.