Clinical Research Services

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Our Services

Every 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: negotiations with regulatory agencies, study design, study management, clinical data management and programming, statistical analysis, and reporting.

Study Designs and Clinical Investigation Plans

Protocol design and development, site selection and more»

Study Management

Management of site staff, investigators, DSMB, external vendors and more»

Clinical Monitoring

Remote and site monitoring, risk-based monitoring more»

Clinical Data Management

eCRF design, EDC programming, testing and validation, Data Management and more»

Statistical Analysis

Statistical Analysis Reports, Randomization Schemes, Clinical Study Reports, Methods & Results for scientific publications, and more»

Real World Evidence

Real World Evidence (RWE) is the clinical evidence regarding the usage and potential benefits or risks of a medical product as derived by analysis more»

Clinical Investigation Plan/Clinical Protocols

The Nor Consult team have worked on hundreds of drug and device studies. We will create the optimal design for your study and develop an appropriate protocol tailored to your investigational product’s specifics. Our experts can help you identify the best patient population, sample size, control group, optimal length of the follow-up period, etc.

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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 translate to cost-effective results. Contact us today to learn more about our solutions for:

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

High-quality data is the key to a convincing trial outcome. At Nor Consult, LLC, we ensure all data are true, accurate and complete. Comprehensive administration of the data management process is guaranteed throughout your study. We utilize a state-of-the art data facility in Seattle, WA to keep your clinical data safe.

  • 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
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Statistical Analysis

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

  • Development of statistical analysis plans
  • 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 diligent on-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. We also provide remote and Risk Based Monitoring (RBM) solutions.

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Real World Evidence

As defined by the FDA, Real World Evidence (RWE) is the clinical evidence regarding the usage and potential benefits or risks of a medical product as derived by analysis.

Nor Consult, LLC has designed, managed, analyzed and reported on RWE projects since 2012. We bring value to your RWE efforts by partnering with Key Opinion Leader physicians, surgeons and researchers at many of the highest-volume medical centers in North America and globally.

Our clinicians and statisticians leverage their academic backgrounds to develop RWE questions that cannot be addressed through traditional clinical trials.

Our Clinical and Data Management teams are experts in developing medical data abstraction solutions that accurately and efficiently gather data in support of client goals.

When needed, we provide temporary staffing solutions to sites in order to assist with abstraction and data-entry. This helps to ensure high-quality data and adherence to project timelines.

Nor Consult’s medical writers help you develop abstracts, manuscripts, presentations and other deliverables appropriate for conferences and industry meetings.

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