Orbis Clinical is a specialized consulting firm that provides drug safety, risk management, regulatory, and quality assurance services to pharmaceutical and biotechnology companies. It has experienced consultants with decades of expertise in these areas. Orbis uses a flexible engagement model to quickly respond to clients' needs with individual specialists or broad-based teams.

1. Orbis Clinical is a specialized consulting firm focused solely on serving the
Drug Safety, Risk Management, Regulatory and Quality Assurance needs of our
clients.
DRUG SAFETY AT Orbis Clinical, we deliver highly qualified consultants to companies in the
pharmaceutical and biotechnology industries. Our flexible engagement model allows
RISK MANAGEMENT us to provide a wide range of tactical and strategic solutions to the challenges our
clients face.
REGULATORY AFFAIRS
QUALITY ASSURANCE THE professionals at Orbis Clinical have decades of experience as leaders in Drug
Safety, Risk Management, Regulatory Affairs, and Quality Assurance. Our niche
expertise has resulted in successful working relationships with the leading
STRATEGIC:
biopharmaceutical companies worldwide.
 Resource/Solution
Development OUR MODEL
 End-to-End Consulting
Engagements Whether the situation requires an individual specialist to address a sudden spike in
 Assessment workload, or a broad-based team chartered to provide an end-to-end solution, Orbis
 Regulatory Response Clinical's delivery model can quickly respond.
 Drug Safety Physician
Practice
Consulting Engagements: Our experts possess decades of high-level,
strategic experience in focused areas of drug safety and regulatory. We only
TACTICAL: work with the top professionals in the industry.
 Project Team Tailored Solutions: The right resources at the right time. Orbis engages in
Development strategic partnerships with leading biopharmaceutical companies to ensure
 Staff Augmentation they will have access to the appropriate experts at the right time in their
clinical development lifecycle.
Orbis Clinical Advisory Services: Call on one of our experts. We have a strong network of
200 Unicorn Park Drive
4th Floor
consultants with a vast range of expertise across all areas of
Woburn, MA 01801 pharmacovigilance. In all likelihood, our professionals have overcome similar
challenges to those you currently face. We offer customized advisory services,
Elizabeth Davies feasibility assessments and creative solutions to our clients.
781-569-0607 x1912
Toll Free: Staff Augmentation: Our experienced recruiters have spent many years
1-866-879-1963 working with some of the best talent in the industry. Our bench may already
Fax: 781-569-0608 include those perfect candidates with niche skills that could properly address
Email:
ldavies@orbisclinical.com your current situation.
.
Providing the world’s leading biopharmaceutical organizations with drug safety, risk management,
regulatory affairs and quality assurance expertise essential in treating devastating disease.

2. Areas of Expertise
DRUG SAFETY
o AE/SAE Case Processing ORBIS Clinical has engaged with our Clients across their
o Individual case review Global Pharmacovigilance Departments. Whether providing
o Regulatory response
o Marketed product support
teams of experienced physicians or outsourcing entire projects
o Clinical trial support for remote work, our Physician Practice has provided the high
o Aggregate Data Review level expertise our Clients require.
o Signal Detection/Trending
o Epidemiology
RISK MANAGEMENT
TO mitigate your risk and ensure success throughout the drug
 Risk Management Plans/MAPS lifecycle, Orbis Clinical has developed the knowledge and
 REMS development and submission skill to respond to your risk management needs. Our experts
 Gap analysis provide comprehensive consulting services to develop, refine,
 Benefit risk assessments and implement your Risk Management plans, strategies, and
 Health Economics and Outcomes
Research
guidelines.
REGULATORY AFFAIRS
o Global Labeling (clinical and post ORIBIS Clinical has the global regulatory expertise to meet
marketed) your analytical, strategic and operational needs. We align the
o Global Submissions (IND, IB, CSR, right capabilities with your projects to help you protect your
NDA, BLA, MAA, etc) drug development investment. Ultimately, we know that
o Regulatory Operations
accurate, timely submissions are key to Regulatory success.
o Chemistry, Manufacturing, and
Controls
o Medical/Regulatory Writing
QUALITY ASSURANCE
 Auditing (Internal and External GxP) TO optimize your operations, Orbis Clinical has developed
 SOP Development/Review
the expertise to assess, improve and support all of your quality
 Process Improvement
 Manufacturing Facilities needs. We work with you to develop and implement standards
 QA/QC/Document Control and guidelines that promote quality assurance.
 Clinical and Vendor sites
 Document Review, Writing, and
Templates
th
Orbis Clinical ◦ 200 Unicorn Park, 4 Floor ◦ Woburn, MA 01801
1-866-879-1963 (toll free) ◦ 781-569-0607 (phone) ◦ 781-569-0608 (fax) ◦ info@orbisclinical.com