Drug and Biologics Temperature Monitoring (Cold Chain)

Brochure

Tri-Fold Brochure

Study Management Temp Monitoring

Cold Chain Management Ad

Drug and Biologics Temperature Monitoring
(Cold Chain)

YOUR FIRST CHOICE FOR QUALITY, COST-EFFECTIVE DRUG & BIOLOGICS TEMPERATURE MONITORING

During clinical studies, monitoring of temperature sensitive drug and biologics is imperative for safety and efficacy. Our professional Study Analysts will work with your study team and clinical sites to ensure that product is received, stored, and transferred at appropriate temperatures. We will perform an initial evaluation of site cold chain capabilities, as well as provide hands-on training and guidance to facilitate long term compliance.

Drugs and Biologics can require continuous temperature monitoring from manufacture to subject administration in order to document safety and efficacy. BMA will manage continuous temperature monitoring to ensure that the cold chain is adequately maintained

STUDY COLD CHAIN DEVELOPMENT
Proactive Planning

• Development of study-level procedures
• Creation of temperature monitoring documentation
• Delivery of customized training to sponsor team and monitoring staff
• Selection of temperature monitoring equipment based on sponsor provided specifications

COLD CHAIN CAPACITY
Mitigating Risk

• Assessment of site cold chain storage capability
• Identification of resolutions to impediments in appropriate transport and storage of temperature sensitive drugs and biologics
• Evaluation of existing site temperature monitoring systems to ensure compliance with sponsor specifications
• Provide training to site staff on cold chain practices

CONTINUOUS COLD CHAIN MONITORING
Quality Management

• Ongoing site monitoring for cold chain compliance
• Dissemination of study specific temperature monitoring devices
• Facilitate transport and storage deviation reporting
• Identify and enable fulfillment of corrective action plans

CUSTOMIZABLE SERVICES
Tailored Partnership

• Audit-ready documentation prepared and maintained
• Employ the use of sponsor and distributor’s randomization and distribution systems
• Certified field monitors to conduct initiation, interim & closeout visits
• Negotiation of site specific cold chain budgets
• Maintenance of sponsor systems & databases

7th Cold Chain Distribution for Pharmaceuticals

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

7th Cold Chain Distribution for Pharmaceuticals
Date: September 21st – 24th, 2009
Location: Pennsylvania Convention Center, Philadelphia, PA
Booth:
Info: Website















Cold Chain Management Ad

American Society of Clinical Oncology - ASCO 2009

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

ASCO 2009
Date: May 28th – June 2nd, 2009
Location: Orlando, FL
Booth: 2184
Info: Website

Parnership with CROs 2009 Booth 202

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

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