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Biometrics CRO Services

Renowned expertise

Over the last 25 years LINK Medical has delivered more than 500 clinical trials to Sponsors with study sites in more than 50 countries. We have a broad experience in all major therapeutic areas, Phase I-IV studies, and medical device investigations. We understand that to support the delivery of superior clinical outcomes, your clinical studies require complete control on study data and data analysis. Our team of biometrics specialists are key members in all our clinical project teams and provide input to study design, data collection, validation, and analysis. As master users of Viedoc™, the cutting-edge electronic data capture (EDC) system, we are using our unique expertise to design optimal eCRFs for your trial, with all the sophisticated functions needed to make the data collection and review process as efficient as possible for sites and monitors, and at the same time ensure oversight for you as a Sponsor. Our team is always on hand to provide guidance and planning for full optimization of your trial, in order to meet your objectives and ensure the delivery of high-quality data.

Overview of Biometrics services

eCRF Design:  

  • Set-up– development of an advanced and user-friendly eCRF according to industry standard data structure with smart and adequate built-in edit checks facilitating real-time data cleaning. The set-up is managed by a dedicated project manager who will make sure the eCRF is designed optimally for your trial and applicable users
  • Offline checks –our SAS programmers can develop any custom check needed for your trial. Offline checks are run at defined intervals to ensure high-quality data in your trial
  • eCRF training – clinical sites and sponsors will be trained by our Biometric Project Managers to ensure effective use and a good understanding of the eCRF system
  • Site user management – sites and users are managed you dedicated project managers so that appropriate access is ensured during the course of the trial
  • eCRF documentation – documentation regarding design, testing, validation, and changes to the eCRF is provided for your study file
  • 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
  • Post-production changes – we will work with you to accommodate any changes required to the eCRF after it has been set in production
  • Telemedicine – we are using the Viedoc Connect™ suite to facilitate secure video calls between sites and study participants
  • Patient Reported Outcomes/ Clinical Outcome Assessments – Patient diaries, questionnaires, or assessments can be seamlessly integrated into Viedoc™ and study participants can report their own data in Viedoc Me™ via their smartphones, tablets, or computer for maximum flexibility

Data Management:

  • 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
  • Data Management Plan – for every trial we develop a detailed plan on how study data is captured and handled from study start to database lock.
  • 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
  • Data entry – our processes ensure high-quality transfer of study data from paper or other sources to the clinical database for your trial
  • Study-specific reports – depending on your requirements we can develop tailored study reports for your trial
  • 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
  • Medical Coding – depending on your requirements our trained medical coders perform coding according to ATC, MedDRA, and/or WHODdrug dictionaries
  • Outsourcing and consulting – our team of experts is available for short term or long-term consulting to ensure you have the necessary resources for your projects

Biostatistics:

  • Study design – with our biostatisticians included from the start, we can ensure optimized study design, sample size calculation, statistical methods, and study data endpoints.
  • Randomization schedule – for your randomized trial the biostatistician will carefully select the appropriate randomization schedule to ensure study participants are randomly assigned to one of the treatment regimes in the trial
  • Statistical Analysis Plan (SAP) – based on the protocol the trial biostatistician will create the SAP that outlines in detail the planned analyses with respect to trial 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 for your planned clinical trial
  • Publications – our medical writing team in collaboration with our biostatisticians work together to 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

Head of Department

Jo Anders Rønneberg,

Director, Biometrics
Contact via email

Jo Anders holds a Ph.D. in Molecular Medicine and has over 17 years of experience within research and the CRO industry. Jo Anders has been part of the Oslo team in LINK Medical since March 2011. Jo Anders has extensive experience in running phase I-III clinical trials and is an experienced biometrics and clinical operations leader. Today Jo Anders is Director of Biometrics where he is responsible for all EDC, Data management and Statistical activities in Link Medical.

 

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