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Dohmen Safety

Description: 

Protecting Your Brand By Protecting Your Patients

 

Biosoteria, Inc. and MedComm Solutions have joined forces to form Dohmen Safety - a continuum of pre and post approval safety and product information management capabilities for life science companies. We provide medical information call center services, strategic risk management consulting services, full service drug safety operational capabilities and world-class award winning pharmacovigilance training and education programs.

 

SERVICES AND CAPABILITIES

 

Medical Information Call Center Operations

  • Toll-free, comprehensive drug/medical information services
  • Inbound and outbound call center
  • State of the art telephony, computer equipment and facilities
  • Validated medical inquiry database
  • Comprehensive support for all customers - healthcare professionals and consumers/patients
  • Staffed by PharmD’s with extensive clinical and pharmaceutical  industry experience
  • All calls answered live within 4 rings by pharmacists front line
  • Educational materials and literature fulfillment within 24 hours of request
  • 24/7/365 availability of clinical staff

 

Safety Reporting Services

  • Identification, intake, processing, output and submission of individual case reports and periodic reports
  • ARGUS Safety Database- Validated and 21 CFR Part 11 compliant
  • Detailed SOPs to comply with client/FDA requirements for safety reporting
  • Skilled M.D., Pharm.D. and R.N staffing with extensive Safety experience/expertise

 

Safety Services

  • Preclinical safety assessment
  • Pharmacoepidemiology
  • Clinical safety surveillance
  • Pharmacovigilance compliance
  • Safety data management solutions
  • Document writing and data analysis

 

 

 

Product Quality

  • Identification, intake, and documentation of product complaints

 

  • ??Retrieval of suspect product
  • Product replacement/credit

 

Clinical Trials

  • Protocol and product information
  • Screening and recruiting for study participation

 

Additional Services and Programs

  • Staffing of Medical Affairs booth at scientific meetings with comprehensive services on-site

 

  • REMS/Risk management programs
  • Training and education programs
  • Clinical Trials call center services
  • eLadder Safety (eLearning curriculum)
  • ??Crisis/product recall phone support
  • Pacific Drug Safety Summit

 

Why Dohmen Safety:

  • Skilled Healthcare Professional Staffing.  Our Call Center staff are exclusively Pharm.D.s with clinical and industry experience.  Our Safety staff includes M.D., Pharm.D. and R.N. experts well versed in product safety and pharmacovigilance.

 

  • Optimum Value. When your product demands the highest level of clinical support – Dohmen Safety delivers the value your customers are seeking.

 

  • Outcomes Oriented.   We provide Medical Information and Safety services that protect your patients and help you achieve success in the marketplace.

Services: 

ADE Evaluation/Drug Safety Assessment, Adverse Event Management/Software, Consulting, Medical Communications, Medical Information, Patient Education, Patient Recruitment, Pharmacovigilance, Telephone Support, Training

Contact Information: 

Dohmen Safety
1900 Powell St #880
Emeryville, CA, 94608, USA
Phone : 5105958289
Fax : 5105958183
Internet : www.dohmensafety.com
Email : hlee@medcomsol.com
Contact Person : Herbert Lee, Pharm.D., M.B.A.