BioPoint Follow Verify

BioPoint is a US-based life sciences consulting organization that brings decades of industry knowledge and expertise to our clients. Recently named #49 on the Inc. 500 list of fastest growing companies in America. BioPoint was founded with a common mission; to create an enduring competitive advantage for our clients and consultants in the pharmaceutical, biotechnology and medical device industries. BioPoint’s consulting services and resources function to accelerate all facets of drug development, ensure compliance at a global level and optimize pipeline value / ROI.

Specialized Consulting Services

BioPoint’s experienced and knowledgeable team helps clients across the pharmaceutical and medical device sector navigate through crucial Regulatory, Product Safety, and Market Access landscapes to successfully bring their products to market. Our client-driven, flexible engagement models can present experts on an as-needed, just-in-time consulting basis, working remotely or embedded onsite with your group. Whether your project calls for tactical reinforcement or specialized strategic guidance, we can help.

• Pharmacovigilance, Drug Safety & Risk Management Consulting – Case Intake, Case Processing, Case Assessment, Signal Detection, Risk Management, Benefit/Risk Assessment, REMS, Pharmacoepidemiology
• Regulatory Affairs Services – Regulatory Submissions, Biologic Formulations, Medical Writing, Regulatory Strategy, Advertising & Promotion, Labeling, CMC, Submissions Management
• Market Access / HEOR Consulting – Observational Study Design, Claims Analysis, Literature Review, Model Development, PRO Design, GVD Development
• Quality Assurance Consulting – Internal & External GXP Compliance and Auditing, Validation, SOP Development, Quality Systems Assessment, Development, Enhancement.
• Clinical Operations & Biometrics – Clinical Trial Management, Medical Monitoring, Clinical Data Management, Biostatistics, GCP Audit, SOP Creation, CRO Evaluation.

http://www.biopointinc.com/
Type	Private
Industry	Health Economics Outcomes Research, Regulatory Affairs, Drug Safety / Pharmacovigilance, Quality Assurance, and Clinical Operations & Biometrics
Founded	2011
Headquarters	401 Edgewater Place, Suite 130 Wakefield, MA 01880 USA
Number of employees	51-200 employees

Services

• Drug Safety & Pharmacovigilance
• Regulatory Affairs
• HEOR
• QA & Compliance
• Clinical Development

Pharmacovigilance

Comprehensive Pre- and Post-Marketing Drug Safety Services

BioPoint has the broad-based experience to provide comprehensive clinical and post-marketed drug safety and pharmacovigilance consulting services to help the client address product safety concerns in a confident, proactive manner.

A pharmacovigilance and drug safety consultant(s) from BioPoint acts as a direct extension of your team to assist with:

• Clinical and Marketed Individual Case Safety Reports – Prepares regulatory-ready serious and non-serious safety reports for clinical and marketed products, ensuring full compliance with client-approved operating procedures from initial event capture to submission-ready regulatory forms.

• Aggregate Safety Reports – Development of all clinical and marketed periodic reports for planned regulatory response, including country-specific reports.

• Scientific Literature Surveillance – Provide outsourced options to support existing client safety organizations.

• Safety Signal Detection – BioPoint can conduct all or part of your clinical and marketed signal detection and analysis.

• Epidemiology Consultation – Oversees the development of study design, data collection and analysis plans, and prepares final reports summarizing study results.

• Risk Management – We assist clients daily with the development of clinical and post-approval strategies. BioPoint also provides pharmacovigilance consulting and planning services, including the development of key clinical and marketed safety specifications and risk minimization plans.

• Regulatory Consultation – BioPoint provides effective regulatory assessment and strategy for product development, including regulatory filings and other consultative services (e.g., post-approval commitments, new drug application strategies and regulatory agency advisory committee meetings).

Top 5 Recent News Headlines

BioPoint, Inc. Named to Boston Business Journal’s 2017 Fast 50 Awards List

• BioPoint Earns Spot on Prestigious Inc. 5000 List of Fastest-Growing Private Companies for Third Straight Year. Aug 16, 2017. Business Insider.
• No surprise: Meet the fastest-growing company in the state. Aug 14, 2015. Boston Business Journal.

Top 5 Lifetime Tweets

1. Exelixis Shoots Up as Cancer Drug Meets Goals in Phase III Trial | BioSpace. Oct 17, 2017. https://twitter.com/biopointinc/status/920295587064504321
2. Big Pharma Gets Boost as China Speeds Up New Drug Approvals. Oct 10, 2017. https://twitter.com/biopointinc/status/920295587064504321
3. Facing an exodus, EMA starts to line up temp replacements as top staffers jump ship. Oct 6, 2017. https://twitter.com/biopointinc/status/916309322149351424
4. Intarcia loses some of its sparkle with FDA rejection. Sep 30, 2017. https://twitter.com/biopointinc/status/914158685215248385
5. Zogenix drug cuts seizure rate in patients with severe epilepsy. Sep 29, 2017. https://twitter.com/biopointinc/status/913772607069212673

References

1. http://www.biopointinc.com/drug-safety-pharmacovigilance/

Top Authors

• BUSRA MAMMADOV
• Cherry Ann Baluyut
• Jeysel Rio D. Cawaling
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