Bringing together the right people to find tomorrow’s solutions.
Validity Research, LLC (VR) is a full service Site Management Organization (SMO), facilitating relationships in the field of medical clinical research. By serving as a SMO, Validity’s intent is to benefit all parties through its networking services. Validity Research specializes in facilitating relationships and brings a new level of service, integration and professionalism to the research industry.
VR provides ethical, quality-oriented, enthusiastic, and experienced clinical research physicians. Validity manages the clinical trials, thus speeding up the site identification, qualification, initiation, budget & contractual negotiations and start-up process. Budgetary and contractual discussions are centralized, minimizing multiple negotiations for each site. Validity's management and operating procedures provide Sponsors and CRO's prequalified physician sites that meet protocol-specific criteria, significantly reducing the time and resources required to evaluate and qualify a site or a Principal Investigator.
Validity management and quality assurance practices complete tasks quickly and accurately. Committed to the successful outcome of each study they participate in, Validity holds patient safety as their #1 priority.
The Validity team of research professionals have over 20 years of experience in the field of clinical research. Our research professionals conduct phase II, III and IV pharmaceutical and device trials, effectively meeting the needs of our sponsors.
Validity Research works with each sponsor to assemble the right team of principal investigator, sub-investigators, coordinators and support staff to meet the specific needs of each trial.
Our therapeutic specialty areas include:
- Asthma
- Bursitis
- Carpal Tunnel Syndrome
- Chronic Bronchitis
- COPD
- Deep Vein Thrombosis
- Degenerative Disc Disease
- Insomnia
- Low Back Pain
- Medical Devices
- Muscular Pain
- Narcolepsy
- Neck Pain
- Non-restorative sleep
- Obesity
- Osteoarthritis
- Osteoporosis
- Pain
- Pneumonia
- Restless Leg Syndrome
- Rheumatoid Arthritis
- Sleep Apnea
- Smoking Cessation
- Spinal Fusion
- Spinal Surgery
- Tendonitis
- Upper Respiratory Tract Infection
Validity Research, LLC, sites are conveniently located within minutes of major roadways, easy to access via the freeway or public transportation with ample parking. To ensure patients' convenience, all study-related interviews, procedures and blood draws are done in the clinic settings of attending principal investigators and sub-investigators.
- Fax machine
- Computers
- Phone systems
- Centrifuges
- ECG machines with interpretation
- -20° Freezer with 24 hour monitoring
- Blood pressure monitors (mercury and digital)
- Secure drug storage (locked, temperature-controlled cabinets)
- Secure Regulatory and CRF storage
- Comfortable workspace for monitors
- Complete Standard Operating Procedures
- Daily Fed Ex, UPS, Airborne pick-ups
- Dry ice available
Amin Khan M.D. - Board Certified Pulmonary, Critical Care and Sleep Medicine
Area of Expertise: Pulmonary and Sleep Disorders
Jeffrey T. MacMillan M. D. - Board Certified Orthopaedic Surgery
Area of Expertise: Orthopaedic, Trauma, Spine
Ann Marie Romaker M.D. - Board Certified Internal Medicine
Area of Expertise: Pulmonary and Sleep Disorders
Validity Research employs qualified, dedicated clinical research coordinators with extensive training in Standard Operating Procedures, FDA, GCP, HIPAA and ICH guidelines.
The staff of VR provide well-coordinated support to our investigators and high-quality service to our sponsors with its years of interdisciplinary experience.
Our professional, staff provides the following services:
- Protocol Procurement & Review
- Resource Planning and Staffing
- Budget & Contracts Negotiation
- Local and Central IRB Approval Processes
- Document Management
- Study Initiation
- Study Subject Recruitment and Retention
- Screening/Enrollment Procedures
- Study Management
- Case Report Form (or eCRF/EDC) Completion
- Correction and Archival Clinical Data Management
- Regulatory Compliance/Quality Assurance
- Coordination of Monitoring Visits
- Study Communications
- Site Close-Out
- Coordination of FDA/Sponsor Audits
Validity Research calls Johnson County, Kansas home. Johnson County is one of eight counties that compose the Kansas City Metropolitan area. Validity Research has investigators with active medical practices in many of the eight counties. The Kansas City Metropolitan area consists of two states, 116 cities, a population of almost two million people, making it part of the 29th largest populated metropolitan area.
Validity Research patient population is diverse in age, gender, economic levels and medical conditions. Research participants are drawn from a computerized database composed of patients seen in the investigator's and subinvestigators' practices.
White, Non-Hispanic - 76.3%
Black, Non-Hispanic - 13.12%
American Indian - 0.8%
Asian - 4.1%
Native Hawaiian/Pacific Islander - 0.1%
Two or more races, Non-Hispanic - 1.5%
Hispanic/Latino - 6.5%
Validity Research uses a Central IRB. We have the ability to use both local or central laboratory facilities.
The turn-around time in submitting regulatory documents average 3-8 days with regulatory process completion averaging 14 days. Budgets are typically finalized within 7 days.
Shannon Cone
Clinical Research Manager
Validity Research LLC
18432 Spruce
Gardner KS 66030
USA
Phone: 913-952-2598
Fax: 913-543-3599
EMail: info@validityresearch.com
Web Site: http://www.validityresearch.com
If you are interested in contacting this center to discuss placing a clinical
trial there, please complete and send the E-mail form below. A representative from
the research center will then follow up with you.
