Clinical Research Services


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Our Services

Each clinical trial is unique. At Nor Consult, LLC, we offer a range of services that can be tailored to fit the needs of your clinical study. These services include, but are not limited to, study design, study management, clinical data management, and statistical analysis.

Nor Consult, LLC, prioritizes having a strong quality management system and attending to the Sponsors' goals. We provide comprehensive onboarding training to our experienced personnel to ensure the highest level of accuracy and precision in each stage of the clinical trial.

Study Designs and Clinical Investigation Plans

Protocol design and development, site selection and more»

Study Management

Site management, medical writing, submissions and more»

Clinical Monitoring

Remote and site monitoring, risk-based monitoring more»

Clinical Data Management

Electronic Data Capture, eCRF design, Data management and Statistical analysis plans, reporting and more»

Statistical Analysis

Complete statistical analysis package, Statistical Analysis Report, Clinical Study Report, publication support, grant application preparation and more»

Clinical Investigation Plan

Clinical trials for pharmaceuticals and medical devices have some critical differences in the way they are designed and executed. All drugs require a clinical trial; however, depending on the region, not all medical devices require a clinical trial. For example, in the United States, Class III and some Class II devices require a clinical trial, while in the EU, even Class I devices require clinical evidence demonstrating that the device meets all regulatory requirements.

Our team at Nor Consult, LLC, has vast knowledge of all aspects of both drug and device studies. We will create the optimal design for your study and design a clinical investigation plan for the Sponsor. Our experts will help the Sponsor identify the best patient population, sample size, control group, optimal length of the follow-up period, etc. We offer our clients comprehensive site identification and selection, as well as strict and effective risk management strategies.

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Study Management

Nor Consult, LLC, offers a comprehensive range of study management services based on your needs. Our expertise and validated solutions in clinical research translates to cost-effective results. These include:

  • Site contracting, compensation and management
  • IRB/REB/EC document preparation, submission, and management
  • Enrollment and retention strategies
  • Regulatory and administrative document management
  • Inspection
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Clinical Data Management

High-quality data is crucial in clinical research. At Nor Consult, LLC, we ensure all data are true, accurate and complete. Comprehensive supervision and management of the data management process is achieved by:

  • Tailored Case Report Form (CRF) design and creation
  • In-house cost-efficient Electronic Data Capture (EDC) systems
  • Data management plan development
  • Data management reporting
  • Development of data transfer specifications
  • Database set-up, validation, programming, data entry, and lock
  • Data verification and query resolution

Our risk-based monitoring strategies include:

  • Remote monitoring
  • Review of trial electronic data for clinical consistency
  • Remote source data verification
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Statistical Analysis

Nor Consult, LLC, offers a comprehensive range of statistical analysis services that include:

  • Development of the statistical analysis plan
  • Design of the statistical aspects of a protocol
  • Sample size determination
  • Randomization
  • Statistical analysis reporting
  • Adaptive design
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Clinical Site Monitoring

At Nor Consult, LLC, our Clinical Research Associates (CRAs) perform strict site monitoring to ensure compliance with the clinical trial protocol, accuracy of case report forms, and adherence to regulations. Each CRA works closely with the Sponsor and Site Personnel to ensure that any issues that may arise during the clinical trial are promptly resolved.

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