B. McLaughlin Associates, Inc. - BMA - Clinical Research Organization (CRO)

DIA 2011 47th Annual Meeting - Drug Information Association

2011-06-05T07:29:00.000-07:00

Upcoming Events

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

DIA 47th Annual Meeting
Date: June 19th – 23th, 2011
Location: Chicago, IL
Booth: 801
Info: Website

A Helping Hand in Clinical Research

2011-01-24T20:13:00.000-08:00

B. McLaughlin Associates, Inc. (BMA) has been a provider of customized, cost-effective clinical research support for over 18 years. Our services for drug, biologics, and device studies include Study Management, Regulatory and Financial Document Collection and Review, Regulatory Document Audits,Clinical Study Contract/Patient Budget Negotiation, Informed Consent Creation, Review and Change Management, Drug and Biologics Temperature Monitoring (Cold Chain), Data Management, and Clinical Scientist Support.

We recognize the importance of a successfully run clinical trial and have the industry experienced staff to enhance your study team and create positive results. Our Study Analysts, Data Analysts, and Study Managers will professionally run your projects to ensure timely completion of all contracted tasks, while keeping quality, accountability, and compliance paramount. Whether your outsourcing requirements are for the full life cycle of a clinical trial or just for a specific need, BMA is here to provide a flexible solution.

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

Therapeutic Experience

2011-01-24T20:12:00.001-08:00

Therapeutic Experience BMA has extensive experience supporting over 200 clinical trials across a broad range of therapeutic areas and indications. Clinical indications we have worked on over the past 18 years include:

	Biologics	Cancer	HSV
		Breast	HPV
		Lung (Non-Small Cell)	Influenza
		Melanoma	Pertussis
		Myeloid Leukemia, Acute	Polio
		Diphtheria	Tetanus
		Hepatitis B

	Cardiovascular	Atrial Fibrilation
		Congestive Heart Failure (CHF)
		Congestive Heart Failure (CHF), Pediatric
		Coronary Heart Disease

	CNS	Cancer – Brain
		Insomnia
		Restless Leg Syndrome, Adolescent
		Progressive Multifocal Leukoencephalogy

	Dermatology	Psoriasis
		Wound Healing

	Endocrinology	Diabetes Type 1
		Diabetes Type 2
		Diabetes Type 2, Pediatric

	Gastroenterology	Cancer – Gastroesophageal

	Hematology	Idiopathic Thrombocytopenia Purpura
		Lymphocytic Leukemia, Chronic
		Non-Hodgkin’s Lymphoma
		Thromboembolism Prevention

	Infectious Disease	Diphtheria	Otitis Media
		Hepatitis B	Pertussis
		Hepatitis C	Pneumonia
		HSV	Polio
		HPV	Sepsis
		Influenza	Sinusitis
		Lyme Disease

	Musculoskeletal Disease	Cancer – Sarcoma, Soft Tissue

	Nephrology	Cancer – Renal Cell
		Hepatitis C
		Liver Disease, Chronic

	Oncology – Cancers	Brain	Lymphocytic Leukemia
		Breast	Melanoma
		Cervix	Myeloid Leukemia, Acute
		Colorectal	Non-Hodgkin’s Lymphoma
		Esophagus	Other
		Gastric	Ovary
		Head and Neck	Prostate
		Kaposi’s Sarcoma	Renal Cell
		Lung (Non-Small Cell)	Soft Tissue
		Lung (Small Cell)	Solid Tumors

	Ophthalmology	Cancer Safety Follow-up

	Other	Chemo-Induced Nausea & Vomiting
		Post-Surgical Nausea & Vomiting

	Respiratory	Asthma
		Cancer – Lung
		Chronic Obstructive Pulmonary Disease

	Urology	Benign Prostatic Hyperplasia
		Cancer – Prostate

	Women’s Health	Cancer
		Breast
		Cervix
		Ovary
		HPV

Who BMA Supports

2011-01-24T20:09:00.000-08:00

Who BMA Supports

BMA offers both niche and full support services to Sponsors, Clinical Sites, CROs, Government Agencies and Vendor Service Providers (laboratories, radiologists, imaging, etc.).

www.bmclaughlin.com/contacts.html

BMA Woman-Owned Certification

2010-04-22T11:59:00.000-07:00

BMA is pleased to announce that we have been granted Women's Business Enterprise National Council (WBENC) Certification. Hundreds of major corporations turn to the WBENC to identify women-owned businesses to satisfy their contract needs because WBENC issues a Gold Standard, national certification to women owned businesses to ensure a qualified database of WBENC Certified Women Business Enterprises (WBEs).

Drug and Biologics Temperature Monitoring (Cold Chain)

2009-12-01T07:53:00.000-08:00

Brochure

Tri-Fold Brochure

Study Management Temp Monitoring

Cold Chain Management Ad

Drug and Biologics Temperature Monitoring (Cold Chain)

2009-12-01T07:39:00.000-08:00

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

2009-09-25T12:49:00.000-07:00

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

2009-05-15T14:28:00.000-07:00

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

2009-04-19T22:55:00.000-07:00

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

2009-02-22T16:07:00.000-08:00

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

2009-02-22T16:01:00.000-08:00

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

2009-02-22T15:56:00.001-08:00

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

2009-02-22T15:50:00.000-08:00

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

A Helping Hand In Clinical Research

2008-02-15T11:38:00.000-08:00

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.

New Domains - Subdomains

2008-01-20T08:54:00.001-08:00

Domains
www.regulatorybma.com
www.bmaeast.com
www.bmawest.com
www.bmclaughlinassociates.com

Subdomains
www.researchservices.bmawest.com
www.pharmaceuticalservices.bmawest.com
www.regulatory.bmawest.com
www.clinicalconsulting.bmawest.com
clinicalresearchorganization.bmawest.com

BMA - B. McLaughlin Associates, Inc. East

2007-06-01T14:23:00.000-07:00

B. McLaughlin Associates, Inc. East

Our corporate headquarters are located in West Chester, PA, which is 30 minutes from Philadelphia.

1540 McDaniel Drive
West Chester, PA 19380
Tel: (610) 430-1847
Fax: (610) 430-1970

BMA - B. McLaughlin Associates, Inc. Brochure

2007-05-14T14:27:00.000-07:00

BMA - B. McLaughlin Brochure

Please download the latest version of our brochure.

B. McLaughlin Associates, Inc.

2006-12-15T10:29:00.000-08:00

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.

www.regulatorybma.com

BMA - B. McLaughlin Associates, Inc. West Coast

2006-08-21T10:57:00.000-07:00

B. McLaughlin Associates, Inc. West Coast

We recently expanded into our Phoenix, AZ office, which opened in August 2005.

16515 S. 40th Street, Suite 125
Phoenix, AZ 85048
Tel: (480) 659-9120
Fax: (480) 659-9193

Project Management

2006-07-03T14:13:00.000-07:00

Project Management

BMA will assign the best team member to your project, according to their experience and expertise, and will work together with you to achieve the most accurate and on-time completion of your project. We will work as a cohesive team with your company and, as needed, will expand our capabilities to fit your needs. We pride ourselves on a job well done!

B. McLaughlin Associates, Inc.

Additional Services

2006-06-02T14:12:00.000-07:00

Additional Services

Our services extend to the following, as well:

• Global Resource Management
• Contract and Grant Negotiation
• Quality Assurance
• Meeting Planning
• Travel Arrangements and Planning
• Graphic/Web Design
• Large Format Digital Printing
• Signs and Promotional Items
• Document Archiving
• Mailing and shipping

When you need help, BMA is here to assist you!

Data Management

2006-05-02T12:16:00.000-07:00

Data Management

Distribution and Collection of Data Discrepancies

BMA will distribute and collect data discrepancy queries within an average of 7-14 days from clinical sites in the Americas and throughout the world. During the life of a clinical trial and, most importantly, at interim and final deadlines, the timely return of accurate data is crucial. BMA can help ensure that, through constant communication with clinical sites and monitors, your clinical trial is not jeopardized.

Serious Adverse Event Narratives and Reconciliation

Serious Adverse Event retrieval for timely reporting to Regulatory Authorities, as well as writing SAE Narratives and Reconciliation, are prepared according to sponsor specifications.

CRO Interaction and Monitoring

Through our extensive experience with major CROs, metrics for data management of study data can be developed, as well as monitored to ensure on-time delivery of clinical data to meet sponsor deadlines.

Clinical Indications

2006-05-02T12:14:00.000-07:00

Clinical Indications

BMA has worked on clinical trials for the following indications:

Avoidance of Vascular Occlusion
Arrythmias
Hypertension
CHF
COPD
Wound Healing
Diabetes
Otitis Media
RSV
AECB
Pneumonia (CAP & Nosocomial)
Pyelonephritis
UTI
Sinusitis
Sinusitis Epidemiology
Herpes Simplex
Ovarian Carcinoma
Kaposi's Sarcoma
Small Cell Lung Cancer
Colorectal Cancer
Acute Myelogenous Leukemia
Multifocal Leukoencephalopathy
Lyme DiseasePediatric RLS
Sepsis
Breast Cancer
Coronary Heart Disease
Thromboembolism
Thrombocytopenia
Influenza Vaccine
HPV Vaccine

BMA - B. McLaughlin Associates, Inc. (CRO)

2006-05-01T14:32:00.000-07:00

Featured Services

Study Management

Preparation and Distribution of Study Initiation Packets

BMA will reproduce and prepare study initiation packets & regulatory binders and distribute them to clinical sites. Accurate and on time shipments ensure that your clinical trial will meet the best possible start

Collection of Regulatory and Financial Documentation

BMA will work with clinical sites to collect all regulatory and financial documentation required for study start-up. We recognize that one of the most critical steps of the clinical trial process is ensuring that sites are ready for initiation as soon as possible.

BMA will also collect ongoing documentation throughout the duration of the clinical trial. This includes, revised 1572s, certification renewals, annual/semi-annual IRB renewals and all documentation relating to amendments and modifications. Once documents are collected from clinical sites and reviewed and approved by BMA, they can be returned to the Sponsor, or filed and retained in our office until the end of the study.

Upon study completion, BMA will collect all study close-out documentation, e.g. Finanical Disclosure Forms Part B, Notification to IRB of study close-out, etc.

Negotiation of Clinical Study Agreements and Per Patient Budgets

BMA will produce, distribute and negotiate Sponsor approved Clinical Study Agreements and Per Patient Budgets. Using pre-specified guidelines, we will work to negotiate the best possible budget on behalf of the Sponsor.

Review and Approval of Informed Consent Forms

Using FDA and Sponsor specified guidelines, BMA will work with clinical sites to ensure that all required Informed Consent Forms contain the appropriate language and information. Distribution of Study Wide Correspondence
Throughout the clinical trial, BMA will reproduce and distribute study-wide correspondence on behalf of the Sponsor.

Regulatory Document Audits

BMA will review study and investigator files for correct and complete content. Once discrepancie

B. McLaughlin Associates, Inc. - BMA - Clinical Research Organization (CRO)

DIA 2011 47th Annual Meeting - Drug Information Association

Upcoming Events

A Helping Hand in Clinical Research

Therapeutic Experience

Therapeutic Experience

Who BMA Supports

Who BMA Supports

BMA offers both niche and full support services to Sponsors, Clinical Sites, CROs, Government Agencies and Vendor Service Providers (laboratories, radiologists, imaging, etc.).

BMA Woman-Owned Certification

Drug and Biologics Temperature Monitoring (Cold Chain)

Drug and Biologics Temperature Monitoring (Cold Chain)

Drug and Biologics Temperature Monitoring (Cold Chain)

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

STUDY COLD CHAIN DEVELOPMENT Proactive Planning

COLD CHAIN CAPACITY Mitigating Risk

CONTINUOUS COLD CHAIN MONITORING Quality Management

CUSTOMIZABLE SERVICES Tailored Partnership

7th Cold Chain Distribution for Pharmaceuticals

American Society of Clinical Oncology - ASCO 2009

Parnership with CROs 2009 Booth 202

Study Management

YOUR FIRST CHOICE FOR QUALITY, COST-EFFECTIVE STUDY MANAGEMENT

Data Management

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

Upcoming Events

Clinical Monitoring

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

A Helping Hand In Clinical Research

New Domains - Subdomains

BMA - B. McLaughlin Associates, Inc. East

BMA - B. McLaughlin Associates, Inc. Brochure

B. McLaughlin Associates, Inc.

BMA - B. McLaughlin Associates, Inc. West Coast

Project Management

Additional Services

Data Management

Data Management

Clinical Indications

Clinical Indications

BMA - B. McLaughlin Associates, Inc. (CRO)

Drug and Biologics Temperature Monitoring
(Cold Chain)

STUDY COLD CHAIN DEVELOPMENT
Proactive Planning

COLD CHAIN CAPACITY
Mitigating Risk

CONTINUOUS COLD CHAIN MONITORING
Quality Management

CUSTOMIZABLE SERVICES
Tailored Partnership

YOUR FIRST CHOICE FOR QUALITY,
COST-EFFECTIVE STUDY MANAGEMENT

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