|
|
|
|
|
|
|
Free Newsletters
Archive
My Subscriptions
News by Subject
News by Disease
News by Date
PLoS
Search News
Post Your News
JoVE
Job Seeker Login
Most Recent Jobs
Browse Biotech Jobs
Search Jobs
Post Resume
Career Fairs
Career Resources
For Employers
Regional News
US & Canada
Biotech Bay
Biotech Beach
Genetown
Pharm Country
BioCapital
BioMidwest
Bio NC
BioForest
Southern Pharm
BioCanada East
US Device
Europe
Asia
Market Summary
News
IPOs
Company Profiles
Companies
Events
Research Store
Biotech Events
Post an Event
Real Estate
Business Opportunities
|
|
|
|
By Industry | By Industry Segment | By Services and Suppliers
| By Location
| By Hotbed |
Profile Search
|
..
BioSoteria, Inc.
Drug Safety & Risk Management Specialists
6425 Christie Avenue, Suite 220
Emeryville
California
94608
U.S.A.
Phone:
866-660-5553
Fax:
925-281-6087
|
Description:
From strategic risk management consulting services and full-service drug safety operational capabilities to world-class award winning pharmacovigilance training and education programs, BioSoteria provides unmatched experience, expertise and leadership to support your company’s efforts to maximize your product’s benefit/risk profile.
Services:
BioSoteria’s experienced drug safety specialists integrate seamlessly with your team to provide a full range of pharmacovigilance services, including:
Preclinical Safety Assessment
Clinical Safety Surveillance
Postmarketing Pharmacovigilance
Safety Data Management Solutions
Risk Management
Pharmacoepidemiology
Pharmacovigilance Compliance
Safety Data Analysis and Document Writing
Drug Safety Training and Educational Programs
Preclinical Safety Assessment
• Preclinical toxicology assessments
• Phase 1 protocol development, including safety monitoring and dose selection
• IND applications
• Investigational Medicinal Product Dossier (IMPD)
• Nonclinical sections of CTD
Clinical Safety Surveillance
• Serious adverse event (SAE) case management, data entry, narrative writing, coding, medical evaluation
• Regulatory reporting worldwide
• Investigator and Ethics Committee safety notifications
• Safety Monitoring Plans
• Annual reporting (IND Annual, EU, ASR, DSURs)
Postmarketing Pharmacovigilance
• Spontaneous ADR case management, coding, medical evaluation
• Regulatory reporting worldwide
• EU Qualified Person in Pharmacovigilance (EU-QPPV) services
• Eudravigilance certified staff for E2B reporting
• Literature ADR review
• Periodic reporting
Safety Data Management Solutions
• Hosted database and implementation of safety database solutions
• Safety data migration
• Aggregate data integration and analysis
• Signal detection and analysis
• Eudravigilance certified staff for E2B reporting
Risk Management
• US Risk Mitigation and Evaluation Strategies (REMS) and REMS assessments
• EU Risk Management Plans (RMP) including safety specification and pharmacovigilance plans
• Developmental RMP (DRMP)
Pharmacoepidemiology
• Evaluation of background disease and event rates
• Safety signal detection and analysis using healthcare databases and FDA AERS data
• Safety endpoint and observational study design
• Establishing or enhancing client pharmacoepidemiology functionality
Pharmacovigilance Compliance
• Safety department and vendor audits and inspection preparedness
• Needs assessment and gap analysis
• Regulatory inspection corrective actions
• SOP development and training
• Staff drug safety training and other corrective and preventive actions
Safety Data Analysis and Document Writing
• IND applications/ IMPD
• Clinical study reports
• Periodic safety update report (PSUR)
• Periodic adverse drug experience report (PADER)
• IND annual and EU Annual Safety Reports
• Developmental safety update report (DSUR)
• Document preparation for data
• Monitoring committees (DMC) and event review/ adjudication committees
• Patient narrative writing
• NDA, BLA and MAA document writing
• Cumulative safety data analyses: integrated summary of safety (ISS), summary of clinical safety, and postmarketing datasets
Other Safety Services
• Legal expert witness
• Crisis Management
• Preparation for FDA advisory committee meetings
• Clinical hold for safety issues
• Expanded /early access programs
Email:
contact@biosoteria.com
Ownership:
Private
Web Site:
BioSoteria, Inc.
Employees:
Symbol:
|
|
|
Company News |
Dohmen’s BioSoteria, Inc. Calls for Abstracts for Its Seventh Annual Pacific Drug Safety Summit (PDSS)
5/31/2013 11:13:50 AM
More...
|
BioSoteria, Inc.'s 6th Annual Pacific Drug Safety Summit, Slated for September 20 - 21
8/6/2012 9:22:28 AM
More...
|
Dohmen Acquires BioSoteria, Inc., the Market Leader in Drug Safety and Education
4/3/2012 9:58:01 AM
More...
|
University of Maryland School of Pharmacy Adopts BioSoteria, Inc.'s eLearning Drug Safety Courses
6/1/2010 12:01:44 PM
More...
|
Drug Safety Firm BioSoteria, Inc. Receives Women's Business Enterprise Certification
5/21/2010 2:40:35 PM
More...
|
Drug Safety Firm BioSoteria, Inc. to Present on eLearning Development Experience
4/29/2010 2:38:33 PM
More...
|
Drug Safety Firm BioSoteria, Inc. Receives 2009 Best of Business Award
3/25/2010 2:21:03 PM
More...
|
BioSoteria, Inc. eLearning Executive Michelle Flewell Selected for Accreditation Council
3/11/2010 3:00:15 PM
More...
|
Drug Safety Firm BioSoteria, Inc. Announces Exponential Growth in 2009
1/29/2010 10:14:56 AM
More...
|
BioSoteria, Inc. Launches Second Online Drug Safety Course in the eLadder(TM) Safety Series
5/15/2009 9:53:27 AM
More...
|
|
|
|
 |
|
|
|
|
|
|
|
|