Sunday, February 22, 2009

Study Management

YOUR FIRST CHOICE FOR QUALITY,
COST-EFFECTIVE STUDY MANAGEMENT

Our team has the experience and industry knowledge required for successful study management.

BMA can help you meet your corporate and product development goals by supporting many aspects of your clinical trials. We allow you to focus on other critical functions, effectively getting more out of your internal resources.

"Get the most out of your study and resources by partnering with BMA"

Our goal is to provide world class support services that keep your projects on time, within budget and compliant to all regulatory authorities.

  • In-House CRA Responsibilities
    • Feasibility & Site Selection Activities
    • Creation, Collection & Review of Regulatory Documentation
    • Negotiation of Contracts & Patient Budgets
    • Maintenance of Sponsor Systems & Databases
    • Drug & Biologics Temperature Monitoring Study Closure Activities
    • Regulatory Document Audit & FDA
    • Submission Support
    • Site Consultation & Support
    • Safety Information & Correspondence Distribution
    • Patient Tracking & Post-Study Follow-Up Provides Support to Field Monitors
  • Clinical Study Manager Responsibilities
    • Study Budget Creation, Review & Maintenance
    • Informed Consent Creation, Review & Maintenance
    • Investigator & CRA Meetings
    • Study Team Management
    • Recruitment & Enrollment Tracking
    • Investigator Site & IP Management
    • Study Timeline Planning & Adherence
    • Provides Direction to Field Monitors

"Your Needs, Our Solution"

http://www.bmclaughlin.com/Study_Management.html

Data Management

YOUR FIRST CHOICE FOR QUALITY,
COST-EFFECTIVE GLOBAL DATA MANAGEMENT SUPPORT

Timely receipt of accurate clinical data is a necessity. BMA has over 15 years of experience in Data Management.

Accurate and complete data for submission to regulatory agencies around the world is critical for clinical studies. Our staff will work with your investigative sites, field monitors, and the study team to promptly collect and review data for precision throughout the life cycle of your trial.

"Get the most out of your study and resources by partnering with BMA"

Our goal is to provide world class support services that keep your projects on time, within budget and compliant to all regulatory authorities.

  • Rapid Data & Query Turnaround
  • Paper & eCRF Expertise
  • Global Support Capabilities
  • Deadline & Rescue Support
  • Data Discrepancy/Query, Dissemination, Collection & Review
  • Data Form Collection & Review
  • eCRF User Support & Site Training
  • Laboratory Normal Range Collection, Transcription & Reconciliation
  • Sponsor & Site Data Entry
  • Patient Tracking & Post-Study Follow-Up
  • Clinical Scientist Support
    • Patient Profile Review
    • SAE & Narrative Review & Reconciliation
    • Data Point Review
    • Query Generation
    • FDA Submission Support
http://www.bmclaughlin.com/Data_Management.html

Upcoming Events

B. McLaughlin Associates, Inc. will be an exhibitor or attending the following upcoming events. We look forward to seeing you there!

18th Annual Partnerships with CROs
Date: April 28th – 30th, 2009
Location: Orlando, FL
Booth: 202
Info: Website

















Clinical Monitoring

YOUR FIRST CHOICE FOR QUALITY, COST-EFFECTIVE ON-SITE MONITORING SERVICES

Ensuring that your trial has quality data, is compliant with all applicable regulations, and meets all timelines is a must for success.

Allow BMA field monitors to work with you and your clinical sites to help meet corporate and study timelines by providing monitoring support throughout all phases of a clinical trial. Our professional, industry experienced monitors will support your sites from feasibility through study closeout, as well as assist with audit preparation and submission support.

  • On-Site Monitoring Activities
  • Certified Field Monitors
    • ACRP
    • SoCRA
  • Site Feasibility, Qualification & Selection Support
  • Initiation, Interim and Closeout Visits
  • Source Documentation Review & Data Verification
  • Data Discrepancy/Query Support
  • Regulatory Compliance Support & Review
  • IRB Documentation Review
  • Site Preparation for FDA & Sponsor Audits
  • Participation & Presentation at Investigator Meetings
  • Enrollment Review
  • Identification & Addressing of Protocol Deviations & Violations
  • Study Supply Inventory
  • Reporting of Adverse Events & Serious Adverse Events


http://www.bmclaughlin.com/Clinical_Monitoring.html