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CROMS

Building the infrastructure and providing full-scope research services for groundbreaking studies of oral, dental, craniofacial, and other related diseases and disorders

Through the Clinical Research Operations and Management Support (CROMS) contract with the National Institute of Dental and Craniofacial Research (NIDCR), Rho provides comprehensive research support services to a variety of clinical studies.  The NIDCR supports clinical research on the cause, incidence, prevalence, prevention, and treatment of oral, dental, craniofacial diseases, and other related diseases and disorders

On a per-study basis, Rho support includes one or more of the following services:  protocol design/development; project and site managementregulatory consulting and management; clinical research operations and study monitoringdata managementsafety managementbiostatistics; and manuscript and regulatory document preparation. The table below provides the number of NIDCR studies that have received specific study services as part of the CROMS contract.  Note that this information is provided only as an illustration of the types of specific services we have provided; this table does not include every service provided for this contract.

Number of Studies Provided Key Services via the CROMS Contract as of January 2014

Service

#Studies

Biostatistical Programming/Analysis

14

Clinical Data Management

12

Clinical On-site Monitoring

42

Full or Supplemental Project Management

27

IND/IDE Regulatory Support

7

Medical Monitoring

21

Protocol and Manuscript Development/Review

18 items

SAE/UP Management and Reporting

40

Safety Oversight (DSMB)

37

Training

35

Study Initiation/Activation Support

18

Study Materials Support

20

Study Websites

506

 

In addition to study-specific operational support, Rho has collaborated in the development of an extensive and publically available Clinical Research Toolkit to facilitate all aspects of clinical research. Rho also provides a secure program website that is accessible by all NIDCR staff and NIDCR funded research teams. The website includes dynamic announcements; staff directories; calendars; study and committee areas for document storage, access, and reporting; document versioning tools; grant and study level data collection and software for portfolio management, reporting, and analysis.

The CROMS group at Rho is led by Dr. Nancy Yovetich, Principal Investigator, and Cathie Snyder, Program Director.

For more information about select NIDCR CROMS studies during the current reporting period, please see below. Note that the studies listed below are examples of studies for which CROMS provides or has provided research services in multiple functional areas.

ClinicalTrials.gov ID

Protocol

Title

NCT01316770

Alevizos 11-D-0094: Parotid Irrigation

Dexamethasone Irrigation of the Parotid Glands in Primary Sjogren's Syndrome Subjects

NCT00395538

Gafni 07-D-0016: PTH

Effects of PTH Replacement on Bone in Hypoparathyroidism

NCT01078467

Gutkind 10-D-0020: OWH

The Molecular Anatomy of Oral Wound Healing

NCT01195922

Gutkind 10-D-0180: mTOR

Rapamycin Therapy in Head and Neck Squamous Cell Carcinoma

NCT00804154

Heiss 09-D-0039: RTX

Resiniferatoxin to Treat Severe Pain Associated with Advanced Cancer

NCT01568697

Moutsopoulos 12-D-0100: Oral Micro

Oral Bacteria and Immune System Problems Involved in Gum Disease (Periodontitis)

NCT01489839

Teles 10-174-E: Biomarkers of PDP

Biomarkers of Periodontal Disease Progression

NCT01748812

Gafni T-D-0030: Cinacalcet

Open-label Dose-titration Study of the Tolerability and Efficacy of Cinacalcet to Treat Fibroblast Growth Factor 23 (FGF-23)-mediated Hypophosphatemia

 

For more information about studies that do not require ClinicalTrials.gov registration, please see below.

Protocol

Title

Alevizos  06-D-0206 AdhAQP1

Open-label, dose-escalation study evaluating the safety of a single administration of an adenoviral vector encoding human aquaporin-1 to one parotid salivary gland in individuals with irradiation-induced parotid salivary hypofunction

McDevitt  09-018-E AMI

Development of a Lab-on-a-Chip System for Saliva-Based Diagnostics

McDevitt  09-020-E OSCC

Characterization of suspicious Oral LESIONS Using Novel Lab-on-a-chip Ensembles

Zajac 13-020-E

Development of Stop Consonants in Children with Repaired Cleft Palate