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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.
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Contents:
Studies
Support
Data
Management
Safety
Reporting
Quality
Assurance
Statistical
Analysis
Research
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