Biostatistics

EXPERTS IN DATA MANAGEMENT AND STATISTICAL ANALYSIS

Our dedicated team of Clinical Data Managers, and Biostatisticans play a key role in ensuring a successful trial.

Together they have a long track record of reliable support for a diverse range of development projects, regardless of their size, therapeutic area, or complexity.

Working as an extension of your in-house team and putting your needs first, they are always on hand to provide guidance, planning and ensure delivery of high-quality data and full optimization of your trial.

• eCRF design– designing an building advanced and user-friendly eCRFs according to industry standard data structures with smart and adequate built-in edit checks that facilitates real-time data cleaning . LINK validates and tests the eCRF design and provides documentation regarding design, testing, validation, and changes to the eCRF is provided for your study file.
• Data sampling strategies – our Data managers will work with you to evaluate the data flow in your trial to ensure the capture of high-quality data according to the study protocol/investigational plan
• Decentralized solutions – our EDC solutions facilitates secure video calls between sites and study participants. Patient diaries, questionnaires, or assessments can be seamlessly integrated into the EDC systems and study participants can report their own data via their smartphones, tablets, or computer for maximum flexibility
• Data integration – our dedicated project manager for your study will ensure seamless integration of any external data that needs to be integrated into the eCRF
• Study-specific reports in SAS– depending on your requirements we can develop tailored study reports for your trial
• Data entry – our processes ensure high-quality transfer of study data from paper or other sources to the clinical database for your trial
• Centralized monitoring – Risk Based Monitoring is implemented in all our clinical trials and our Data Managers work closely with the study monitors to solve any data discrepancies or issues by using centralized approaches for monitoring data quality
• Data review and validation – our Data Managers perform regular reviews of the trial data and solve any discrepancies by efficient query handling processes. Standard reports provide Data Managers and Sponsors with study status in real-time
• Medical Coding – depending on your requirements our trained medical coders perform coding according to ATC, MedDRA, and/or WHODdrug dictionaries
• Database lock and archiving –datasets and all documentation related to data collection, data handling, data management, and data processing are safely transferred to the Sponsor at the end of the study
• Outsourcing and consulting – supporting your organization with the knowledge and the expertise you need. Ensuring you have the necessary resources for your projects.

• Study design – with biostatisticians included from the start, we can ensure optimized study design, sample size calculation, statistical methods, and study data endpoints.
• Randomization schedule – our biostatistician will carefully select the appropriate randomization schedule
• Statistical Analysis Plan (SAP) – based on the protocol, our biostatistician will create the SAP that outlines in detail the planned analyses with respect to study objectives and endpoints
• Programming of Analysis Datasets – our biostatisticians and programmers will develop analysis datasets to facilitate the statistical analysis described in the SAP. We have a broad experience using CDISC standard (SDTM and ADaM)
• Statistical analyses – based on the SAP and the analysis datasets, our biostatisticians and programmers will create all the statistical analyses and tables, listings, and figures for the clinical study report
• Interim Analysis – any interim analysis will be performed by our biostatisticians as outlined in the study protocol/SAP
• Data monitoring Committee (DMC) and Data Safety Monitoring Board (DSMB) support– DSMB management and provision of study data for efficient data evaluation
• Input to Clinical Study Report / Statistical report – our biostatisticians work in close collaboration with the medical writer to provide input to the Clinical Study Report, or a separate statistical report can be provided
• Regulatory Authority Meetings – our experienced senior biostatisticians can participate in meetings with regulatory bodies to present and discuss study design and statistical methodology
• Publications – our medical writing team, working together with our biostatisticians, effectively communicate your study results to a wider scientific audience
• Outsourcing and consulting – our team of experts are available for short term or long-term consulting to ensure you have the necessary resources for your projects

Our biometrics specialists are key members in all our project teams and provide input to study design, data collection, validation, and analysis.

This large and experienced in-house team (Data Management and Statistics) has broad experience in all phases and therapeutic areas including Real World Evidence and solutions for Decentralized trials (Telemedicine). And with proven results, through over 500 EDC builds.

They work according to established industry standards (CDISC , GCDMP, ICH GCP E9) and are experts in eCRF design and advanced study designs, (e.g. adaptive seamless trials, umbrella trials, cluster randomized trials and designs for personalized medicine).

They use reliable, well-integrated processes that secure data integrity and quality, ensuring inspection readiness.

As master users of Viedoc^™, the cutting-edge electronic data capture (EDC) system, they have access to all the sophisticated functions needed for efficient data collection and review, with seamless oversight for you as a Sponsor. LINK also has the capability to build clinical databases in various EDC systems as well as Viedoc^™,

An agile organization with short communication lines gives speedy and short timeframes for study deliverables.

Why Biostatisticians are Essential for Successful Clinical Trial Management

The Power of Biostatistics in Clinical Trials – Article

Viedoc Master Users case study

No one beat Viedoc in Start up time

Video: Successful CRO Navigation – A US client perspective on selecting the right CRO, Data Management and collaborating with LINK Medical over a decade