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KAI Research, Inc.

Description: 

KAI Research Inc. (KAI) - Knowledge, Accountability, Innovation
KAI Research Inc. (KAI), an Altarum company, provides product lifecycle study support from Phase I through post-marketing activities to the domestic and International pharmaceutical and biotechnology Industry as well as U.S. government agencies (NIH, CDC, DOD, and FDA). KAI has over 27 years of experience and an in-depth knowledge of research methodology, processes, and medical informatics. KAI has a unique, multi-disciplinary team that offers substantive understanding of the requirements of the regulated clinical development and post-marketing environment. KAI offers a full suite of clinical development and post-marketing services. KAI is a full-service CRO as well as a functional service provider for all services. KAI's areas of excellence include:

CLINICAL STUDIES - "Full service" clinical study assistance from study design through regulatory approval. KAI provides methodological guidance for protocol and materials development, identifies and initiates sites, coordinates study operations, performs statistical analysis, and prepares the regulatory submission for IND, IDE, 510K, NDA, and BLA applications.
CLINICAL DATA MANAGEMENT - Web-based remote data entry appropriate for all phases of clinical studies using our validated, 21 CFR 11 compliant commercial electronic data capture (EDC) system, OpenClinica 3.1TM© Enterprise Edition. OpenClinica is directly linked to our interactive voice recognition system (IVRS), Web-based randomization system (SmartQ), and Clinical Trial Management system (Smart TrialTM©).
CLINICAL SAFETY AND PHARMACOVIGILANCE - Adverse event case management individual case safety report (ICSR) electronic submission, aggregate reporting, trend analysis/signal detection, literature review, medical coding, and medical monitoring. KAI's clinical safety and pharmacovigilance activities are supported by the ARISgTM adverse event tracking and reporting system.
MEDICAL COMMUNICATIONS - Medical information inquiry management, standard response maintenance, booth staffing, medical liaison and sales representative support. Medical communications projects are supported by Smart DeskTM©, a Call Center System that provides call tracking and standardized reports.
DATA STANDARDS, WAREHOUSING AND GOVERNANCE - Development of data standards for an array of diseases while actively involved in the Clinical Data Interchange Standards Consortium (CDISC) and National Cancer Informatics Program (NCIP) communities. KAI also builds data warehouses for completed studies for aggregate data exploration and analysis and provides data governance consultation and implementation processes.
PATIENT REGISTRIES/OBSERVATIONAL STUDIES – The innovative, cost-effective approaches of KAI’s registry and observational study services are easily expanded to include an unlimited number of patient populations to track outcomes, patient population dynamics, and treatments in customized reports.

KAI clinical trials and epidemiological studies encompass adult, pediatric, and geriatric populations. Our professional staff has experience in a wide variety of therapeutic areas including CNS, dermatology, endocrinology, gynecological disorders, infectious disease, oncology, pain, psychiatric disorders, rheumatology, substance abuse, and vaccines.

We are committed to exceeding client expectations through cutting-edge technological tools in clinical research, providing regulatory, scientific, medical, and information technology expert services and providing the most reliable, cost-effective service in our industry.

For further information about KAI Research, visit www.kai-research.com.

Services: 

ADE Evaluation/Drug Safety Assessment, Adverse Event Management/Software, Clinical Study Reports, Clinical Trial Monitoring, Data Management, Electronic Data Capture, Medical Communications, Medical Information, Pharmacovigilance, Quality Assurance/Control

Contact Information: 

KAI Research, Inc.
11300 Rockville Pike, Suite 500
Rockville, MD, 20852, USA
Phone : 3017702730
Fax : 3017704183
Internet : www.kai-research.com
Email : pshugarts@kai-research.com
Contact Person : Patti A. Shugarts, Vice President and COO