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Duke Clinical Research Institute
Duke Clinical Research Institute is listed as a small business research supplier in the Scientist.com network, with 1 site in 1 country and 1 service area.
View Duke Clinical Research Institute on Scientist.com
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Sites
1
Countries
1
Services
What this research supplier says it provides, as listed in the Scientist.com network.
Type of company: Small business
Clinical Consulting
- Pharmacovigilance Oversight Pharmacovigilanve oversight encourages the proposal of a structure for a pharmacovigilance plan and a safety specification that summarizes the identified and potential risks of the product to be addressed...
Clinical Trial Intelligence
- Trial Identification by Therapeutic Agent Clinical Trial Intelligence
Clinical Trials
- Central Imaging The standardized, independent review of medical images
- Clinical Biostatistical Services Analyze and interpret data throughout all phases of clinical trial development.
- Clinical Project Management Management of clinical trial sites, as monitored by various clinical monitoring organizations. Ensure that the clinical trial is being performed according to the correct protocol to uphold the validity of the data...
- Clinical Trial Design Develop study-related protocols, case report forms (CRFs) and database tools for records management.
- Clinical Trial Risk Management Plan that maintains treatment quality throughout lifecycle and improve decision making.
- CTMS- Clinical Trial Management Systems A Clinical Trial Management System (CTMS) is a software platform used by pharmaceutical, biotech, and research organizations to plan, track, and manage the operational aspects of clinical trials
Show all 36 in Clinical Trials
- Digital Recruitment Strategy Design Digital recruitment strategy design involves creating a comprehensive plan that leverages online platforms and technologies to attract, engage, and hire the best talent efficiently.
- Diversity and Inclusion Consulting For Trials Diversity and inclusion consulting for trials involves providing expert guidance to ensure that clinical trials are designed and conducted in ways that include diverse populations and address barriers...
- eCOA - Electronic Clinical Outcomes Assessments Use smartphones, computers and tablets to allow patients to directly report health outcomes.
- eConsent - Electronic Informed Consent Monitor clinical trials through electronic informed consent given by patients.
- EHR to EDC Transfer data from an Electronic Health Record (EHR) system to an Electronic Data Capture (EDC) system, which is commonly used in clinical trials
- eTMF- Electronic Trial Master File Manage essential documents in compliance with regulatory standards
- Informed Consent Development Informed Consent is a prerequisite of any conduct within a clinical trial, and refers to the process in which the permission of the potential clinical trial subject is obtained. Informed consent applies to all...
- Investigator Meeting Planning & Execution Investigator planning and meetings ensure that there is proper communication and reliability during a clinical trial. Allows for efficient work flow.
- Investigator Recruitment Enlist clinical research experts to assist in investigator selection, recruitment monitoring and database evaluation.
- Patient Insights Data, information, and feedback collected from patients to understand their experiences, perspectives, and needs related to a particular health condition or treatment
- Patient Recruitment Recruit and retain patients for clinical trials.
- Pharmacokinetic Studies Design a study that observes the time course of drug absorption, distribution, metabolism, and excretion, as means to test the safety and effective therapeutic management of drugs in an individual patient.
- Phase 1-3 Studies Design phase 1-3 studies that seek to identify if a drug is safe, effective, and more efficient than other available treatments on the market.
- Post-Marketing (Phase 4) Studies Conduct phase 4 studies for confirming unrecognized safety issues, investigating possible hazards or establishing the expected safety profile of a veterinary medicinal product under market conditions.
- Psoriasis Clinical Research Trials Conduct clinical trials to test the efficacy and safety of over-the-counter psoriasis drugs.
- Recruiting Special Populations Recruitment of volunteers who are categorized as part of a special population, or a protected part of the population such as the elderly, women, and children.
- Regulatory Affairs Consulting Receive assistance ensuring compliance with regulatory requirements.
- Regulatory Operations Ensure that all specific regulatory documents are published and properly organized before submission.
- Site Monitoring Maintain oversight over participant's health during a clinical trial.
- Site Selection Select clinical trial sites with clinicians who recruit, enroll, treat and evaluate trial patients.
- Site/Patient Payments Allow for different suppliers to organize the proper patient and site payments for a clinical trial. Provides real-time payments, reduce workloads for site staff and minimize the amount of time participants spend...
- Study/Site Budget Management Secure funding sources and manage contract negotiations for clinical trials.
- Study/Site Feasibility Study Explore and test study practicality.
- Trial Eligibility: Inclusion Criteria Clinical Trial Intelligence
- Trial Identification by Collaborator Clinical Trial Intelligence
- Trial Identification by Geography Clinical Trial Intelligence
- Trial Identification by Investigators Clinical Trial Intelligence
- Trial Identification by Physicians Clinical Trial Intelligence
- Trial Identification by Sponsors Clinical Trial Intelligence
- Wearables / Remote Patient Monitoring Source medical-grade or consumer-grade devices that track patients' vital signs and other health data remotely and wirelessly transmit this information to healthcare providers
Pharmacovigilance
- Adverse Event (AE) and Serious Adverse Event (SAE) Reporting Report unfavourable and unintended events (e.g.: abnormal laboratory results, symptoms or disease associated with treatments) to regulatory bodies via the FDA's Adverse Event Reporting System (FAERS) or other...
- Aggregate Safety Data Review Cumulative summary of safety information regarding the collection, analysis, and submission of aggregated safety data to health authorities at specified intervals.
- IND/CTA Authoring and Publishing Services IND/CTA authoring and publishing services involve preparing, compiling, and submitting Investigational New Drug (IND) applications or Clinical Trial Applications (CTA) to regulatory authorities, ensuring compliance...
- Periodic Safety Update Reports (PSURs) / Periodic Benefit-Risk Evaluation Reports (PBRERs) Preparation of safety reports to report adverse events that occurred during a specified time period. Evaluate if safety profile of treatment has changed since last report.
- Risk Management Plans (RMPs) Develop Risk Management plans (RMPs) that include information on a medicine's safety profile and plans for further pharmacovigilance activities designed to gain greater knowledge. These documents also explain how...
- Safety Advisory Committees Collaborate with global experts to support safety surveillance monitoring and provide guidance on the safety of medicines and vaccines.
Show all 7 in Pharmacovigilance
- Safety Data Management Safety data management involves the collection, analysis, and reporting of data related to the safety of a drug. Including preparing and submitting safety reports to regulatory authorities, which may include periodic...
Service areas:
Clinical
Where it operates
Sites by country, with the cities in each.
-
United States 1 site
About this supplier
In the supplier's own words, as listed in the Scientist.com network.
Duke Clinical Research Institute provides clinical support, data management, safety surveillance, and discovery genomics.
- Website
- www.dcri.org
Work with Duke Clinical Research Institute on Scientist.com
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