Sunday, February 22, 2009

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

Friday, February 15, 2008

A Helping Hand In Clinical Research

B. McLaughlin Associates, Inc.

A Helping Hand In Clinical Research

BMA is a niche provider of clinical research services based in West Chester, Pennsylvania and Phoenix, Arizona. Our services focus on Study Management, Regulatory and Financial Document Retrieval, Clinical Study Agreement/Per Patient Budget Negotiation, Informed Consent Review and Approval, Data Discrepancy Retrieval, and Regulatory Document Audits.

BMA is a highly customizable team and our services can be modified quickly to help you achieve your goals. We have the capabilities and knowledge to expand our service based upon your needs.


Why Choose B. McLaughlin Associates, Inc.?

Being a CRO in the pharmaceutical industry for the past 15 years, B. McLaughlin Associates, Inc. recognizes that you have many options for your sourcing needs. BMA is not a staffing firm or just another service provider. We are so much more than that. So, why choose BMA? We can address this simply by defining our company structure and philosophy. Structurally, we are a small, cross-functional, niche service provider with expertise specializing in Study Management and Data Management. We seek to employ only experienced, highly professional personnel, as we feel that clients should not sacrifice quality in order to meet their outsourcing needs.

As a niche services company, we are able to remain nimble to the fluctuating needs of our clients and truly strive to raise the bar on the quality of service provided by a CRO. At BMA, we are very aware that developing a drug is a long, very costly process. By recognizing the cost-value benefit to clients, our philosophy is to develop a strategic partnership with the intent to fulfill more than just a short-term need, but rather to provide a long-term sourcing solution. We truly believe in acting as a partner with our clients and routinely provide a dedicated, specialized team that can lend knowledge, experience, expertise and consistency to our clients’ studies, internal teams and clinical sites. We make every effort to work with you, not simply for you and will familiarize ourselves with your internal processes and unite them with our own, creating a cohesive, dynamic work team.

B. McLaughlin Associates, Inc.