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Clinical Research Services
About KAI Research, Inc.
Clinical Trial Services
Research Experience
What's New?
Career Opportunities
NIH Studies
Mobis (GSA Schedule)
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Contact KAI
KAI Email
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WBENC Certification

KAI's focus is clinical research support. KAI is devoted to conducting and supporting studies of the highest quality. KAI's areas of excellence include clinical studies support, clinical data management, pharmacovigilance, quality assurance, and health services research.

CLINICAL STUDIES SUPPORT

  • Protocol development through regulatory submission
  • Electronic CRF (eCRF) clinical data capture and management system
  • Clinical monitoring
  • IVRS - Randomization
  • Audits
  • Statistical analysis and programming
  • Clinical study report preparation

KAI offers a range of clinical study assistance from protocol development through successful regulatory approval. KAI staff members write protocols, create CRF's, perform data management; train and initiate sites; manage study operations; monitor sites and prepare safety and efficacy analyses, study reports, and FDA submissions. KAI interacts with sponsors, investigators, and clinical site staff to ensure exemplary studies and products.

CLINICAL DATA MANAGEMENT

One of KAI's strengths is its data management expertise. KAI staff members have developed software applications that include a clinical data management system, Smart Study™©, that supports eCRF's as well as paper forms and centralized data entry.

With eCRF's, study sites transmit data using application hosting technology in an internet environment. Data are edited as they are entered. Study sites, participants and forms are tracked to assist sponsors in proactive study management.

KAI Smart Study™©, which complies with CFR Part 11 requirements, allows rapid startup of studies, extensive editing and direct access by SAS for analysis, and facile report preparation. Our clients attest to our cost-effective approach and monitors recommend the system to other sponsors. In 2003-2004, Smart Study™© supported 37 studies conducted at hundreds of sites sponsored by both industry and NIH.

For additional information on purchasing Smart Study™© contact Scott Brand at KAI.

Other KAI systems include:

  • ARISg - a commercial web based adverse event tracking and reporting system which meets both FDA and ICH requirements, allows for electronic submission of ICSRs in E2B format.
  • Smart Track™© - a proprietary adverse event tracking system that is geared toward FDA requirements. It allows remote access through CITRIX connectivity.
  • Smart Desk™© - a Product Information System that incorporates the best features of call center/help desk software into a specialized system that provides standardized product information to health professionals and consumers.
  • Smart CATI™© - a Computer Assisted Telephone Interview (CATI) system that automates the scheduling of capture of data from health-related surveys or interviews for medical research.
  • IVRS (Interactive Voice Recognition System)
    - a real time method of assigning patients to treatment groups. KAI has used this system for simple, block and adaptive randomization. The system has also been used to survey patients and to collect patient diary information.

All KAI software products are available from KAI as a suite or as individual systems.

PHARMACOVIGILANCE AND SAFETY REPORTING

KAI identifies and reports drug-specific adverse events to the Food and Drug Administration (FDA) and other country's regulatory agencies for marketed drugs and treatments under study.

KAI's product information team responds to telephone, mail, electronic mail, and fax inquiries from consumers, health professionals, and sales persons. The product information team documents the inquiries, provides information, and triages potential safety issues to KAI's full time medical surveillance team.

KAI's medical monitors capture adverse event information, probe for required information, and submit time-sensitive and periodic reports to the FDA.

KAI conducts literature searches and prepares periodic reports for over 40 marketed drugs and is providing safety surveillance for dozens of ongoing clinical trials.

QUALITY ASSURANCE / SYSTEM PROGRAM DEVELOPMENT

For several NIH Institutes, KAI has developed standard operating procedures (SOPs) for reviewing data integrity and for conducting quality assurance assessments. The assessments examine procedures, protocol adherence, data quality, study medication handling, adverse event reporting, and safety and efficacy conclusions. KAI has also conducted numerous audits for industry sponsored studies.

KAI has developed quality systems for clinical researchers based on their individual compliance needs. KAI conducts assessments of current compliance levels and creates a corrective action plan.

KAI carries out on-site assessment of researchers' regulatory risks to GCP/ICH, HIPAA and Part 11. KAI can then assist with the writing of policies and procedures and the development and delivery of training to ensure effective quality system implementation.

STATISTICAL ANALYSIS AND SAS PROGRAMMING

KAI's has an in-house full service statistics group with experience in designing and writing protocols and statistical plans; designing and implementing sampling statistics and randomization procedures; carrying out interim and final analysis of the data. They contribute to the writing of clinical study reports and provide results for submission to the FDA. KAI's staff comprising this group has backgrounds in the pharma industry, NIH and academia.

In addition KAI has developed a battery of SAS programs and macros that can be used to produce the statistical reports, listings and tabulations that are customarily included in IND, NDA and BLA submissions to the FDA, and in support of DSMB meetings. These SAS programs can be quickly implemented to keep programming development time down and get submission ready output to the client.

HEALTH SERVICES RESEARCH

KAI supports health policy, medical effectiveness, and outcomes research. For a pharmaceutical clinical trial for the treatment of BPH and a head injury study, KAI senior staff developed and validated quality of life instruments. KAI's support of both industry and NIH offers clients the experience of both environments. Clients benefit from KAI's exposure to and contacts with world research and academic leadership.

      Page Contents:

    • Studies Support
    • Data Management
    • Safety Reporting
    • Quality Assurance
    • Statistical Analysis
    • Research

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