Services

With a global reach, ClinFocus is dedicated to supporting biotechnology and pharmaceutical companies in achieving their goals and advancing innovative therapies through delivering specialized and integrated biometrics services. Our comprehensive services cover the entire spectrum of biometrics, ranging from early-phase development to late-phase clinical trials coupled with robust clinical trial management services.

EDC Development

We specialize in creating customized Electronic Data Capturing (EDC) solutions that cater to the unique requirements of clinical trials. Our team of experienced developers and clinical trial experts work closely with clients to understand their specific needs and deliver tailored EDC systems that streamline data collection, management, and analysis. As accredited partners of Medidate Rave, our expertise allows us to provide our clients with the highest level of service and support, from initial system setup and configuration to ongoing maintenance and optimization, supporting a wide range of data types, including structured, semi-structured, and unstructured data, and are compatible with various devices and platforms. 

Clinical Data Management

Our clinical data management services include eCRF design, database design, development, and management, edit check development and programming, system validation, user acceptance testing and validation, automated data cleaning and query management, system integration, external vendor management and data reconciliation, medical coding using MedDRA and WHO Drug dictionaries, according to the CDISC and SDTM standards.

Advanced Data Analytics

Our advanced analytics techniques enable us to uncover hidden patterns, trends, and correlations that traditional methods miss. By leveraging these insights, we help our clients make informed decisions, optimize operations, and drive business growth.Using tools such as Artificial Intelligence (AI), SAS, AWS, and Spotfire, we run data analytics to produce robust visualization for clinical data.

Medical Monitoring

At ClinFocus INC, we understand that the heart of any clinical trial is the safety and well-being of its participants. We provide specialized care and oversight to ensure the highest standards of safety throughout every phase of your clinical trials with our Medical Monitoring Services.

Our Expertise

  • Medical Review and Evaluation
  • Participant Safety Monitoring
  • Cross-Functional Collaboration

Safety Data review

Our team of experts can support analysis of safety-related data to identify potential safety concerns and risks associated with the use of the medical product. We do this by developing a safety data review plan, analyzing safety data, and supporting biotech companies in taking key business decisions.

Visualization

Visualization is an important tool for a biotechnology company to effectively communicate complex scientific data and concepts to various stakeholders, including investors, healthcare professionals, and patients. We support biotechnology companies by handling their data visualization, interactive visualization, infographics, and illustrations. By utilizing different visualization techniques, biotechnology companies can enhance understanding, engagement, and collaboration among stakeholders, ultimately leading to the development of innovative medical products that improve patient outcomes.

Site Management

Our team is made up of professionals who have experience overseeing the conduct of clinical trials at the investigational sites to ensure that they are conducted in compliance with regulatory requirements, study protocols, and good clinical practice (GCP) standards. We can support in site selection, site initiation, site monitoring, developing site management plan and conducting site close-out.

Biostatistics

Our dynamic team of experts offers a wide range of biostatistics services that encompass various aspects. These services include developing Statistical Analysis Plans, conducting both Interim and Final Statistical Analyses, creating Manuscripts, providing valuable Statistical insights for trial design and protocols – which involves tasks like sample size calculations, Randomization strategies, and treatment allocation lists. We ensure compliance with CDISC for SDTM domains and generate ADaM datasets.

Additionally, we prepare supplementary documents for the eCRT package and adeptly handle the programming and production of interim as well as final tables, figures, and listings. With our comprehensive expertise, we cover the entire spectrum of biostatistics support to enhance your research endeavors.

Risk-Based Quality Management (RBQM)

At ClinFocus, we implement a robust “end-to-end” strategy to oversee the entire clinical research process, ensuring a standardized and centralized environment that aligns with regulatory expectations and provides effective client oversight. Our audit process for data management is customized to conduct centralized quality reviews of clients’ data management procedures, with the aim of understanding and proactively mitigating quality risks in clinical trials through a Risk-Based Quality Management (RBQM) framework. ClinFocus ensures conscientious appraisals of the methodological quality of our studies from Start-up to close-out.
GET IN TOUCH

For any inquiries, to request additional information, or to receive a tailored proposal for our clinical data services, contact us today!

ClinFocus

We invite you to embark on a transformative journey. As your biometrics service provider, we go beyond ensuring the collection of quality data through efficient and effective study designs.  

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  • 2727 Paces Ferry Road SE Building 1, Suite 750 Atlanta, GA 30339
  • +1(404) 458 9126
  • info@clinfocus.com
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