Cell & Gene Therapy post-approval solutions to reduce scientific, regulatory and commercial risks, and accelerate development wherever you are in your product's development.
Cell & Gene Therapy post-approval solutions to reduce scientific, regulatory and commercial risks, and accelerate development wherever you are in your product's development.
Cell & Gene Therapy enterprise development solutions to reduce scientific, regulatory and commercial risks, and accelerate development wherever you are in your product's development.
Cell & Gene Therapy enterprise development solutions to reduce scientific, regulatory and commercial risks, and accelerate development wherever you are in your product's development.
Medical Device and Diagnostics Solutions for Every Stage of Your Product's De...Covance
Getting a medical device to the patient takes more than good technology in today's environment. Compelling evidence and convincing value proposition matter. Competing priorities and differing stakeholder definitions of value are driving the need for creative, connected strategies to get the most from each step in the development process. And - as evidence is gathered - it should be used to inform and iterate regulatory, reimbursement and clinical post-market strategies.
EMMES is a Contract Research Organization (CRO) dedicated to providing Statistical and Epidemiological Expertise, Data Management, Study Monitoring, Regulatory Guidance and Overall Operational support to clients and collaborators engaged in clinical and biomedical research.
For over three decades, EMMES has steadily and consistently added to our solid record of service to Government Agencies, Pharmaceuticals, Biotech and Device Companies, and Non-profit Organizations.
Cell & Gene Therapy Clinical Development SolutionsCovance
Cell & Gene Therapy clinical development solutions to reduce scientific, regulatory and commercial risks, and accelerate development wherever you are in your product's development.
Advance Your Program in China with Fully Integrated Clinical Development Solu...Covance
Meet your needs for greater efficiency, expanded capacity and customized support at the newly opened Covance Drug Development Center in Shanghai, China.
Cell & Gene Therapy post-approval solutions to reduce scientific, regulatory and commercial risks, and accelerate development wherever you are in your product's development.
Cell & Gene Therapy enterprise development solutions to reduce scientific, regulatory and commercial risks, and accelerate development wherever you are in your product's development.
Cell & Gene Therapy enterprise development solutions to reduce scientific, regulatory and commercial risks, and accelerate development wherever you are in your product's development.
Medical Device and Diagnostics Solutions for Every Stage of Your Product's De...Covance
Getting a medical device to the patient takes more than good technology in today's environment. Compelling evidence and convincing value proposition matter. Competing priorities and differing stakeholder definitions of value are driving the need for creative, connected strategies to get the most from each step in the development process. And - as evidence is gathered - it should be used to inform and iterate regulatory, reimbursement and clinical post-market strategies.
EMMES is a Contract Research Organization (CRO) dedicated to providing Statistical and Epidemiological Expertise, Data Management, Study Monitoring, Regulatory Guidance and Overall Operational support to clients and collaborators engaged in clinical and biomedical research.
For over three decades, EMMES has steadily and consistently added to our solid record of service to Government Agencies, Pharmaceuticals, Biotech and Device Companies, and Non-profit Organizations.
Cell & Gene Therapy Clinical Development SolutionsCovance
Cell & Gene Therapy clinical development solutions to reduce scientific, regulatory and commercial risks, and accelerate development wherever you are in your product's development.
Advance Your Program in China with Fully Integrated Clinical Development Solu...Covance
Meet your needs for greater efficiency, expanded capacity and customized support at the newly opened Covance Drug Development Center in Shanghai, China.
Cell & Gene Therapy Clinical Development SolutionsCovance
Cell & Gene Therapy clinical development solutions to reduce scientific, regulatory and commercial risks, and accelerate development wherever you are in your product's development.
Come and see how we can help you achieve success with your clinical trials as well as safety surveillance activities for your approved product portfolio.
Understand the differences and how a combined HACCP & HARPC plan can be produced. Includes a free pdf which compares the HACCP principles to the Preventive Control Rule and BRC for Food Safety.
Customized Oncology Development Solutions: Clinical Trials Designed Around You®Covance
Oncology is one of the most research-intensive therapeutic areas, yet no two development programs are the same. No two trials are the same. Each one calls for a customized strategy and distinct trial management approach. Covance develops fit-for-purpose solutions Designed Around You® that enable more efficient clinical trials and focus on what is most valuable to your organization.
Supporting Individuals with Intellectual and Developmental Disability During the First 100 Days of the COVID-19 Outbreak in the U.S.
BrightSpring Health Services Chief Medical Officer Dr. William Mills presents on BrightSpring's ongoing response to COVID-19 and how the organization is mitigating risks for our patients, clients, and team members.
Cell & Gene Therapy Clinical Development SolutionsCovance
Cell & Gene Therapy clinical development solutions to reduce scientific, regulatory and commercial risks, and accelerate development wherever you are in your product's development.
Come and see how we can help you achieve success with your clinical trials as well as safety surveillance activities for your approved product portfolio.
Understand the differences and how a combined HACCP & HARPC plan can be produced. Includes a free pdf which compares the HACCP principles to the Preventive Control Rule and BRC for Food Safety.
Customized Oncology Development Solutions: Clinical Trials Designed Around You®Covance
Oncology is one of the most research-intensive therapeutic areas, yet no two development programs are the same. No two trials are the same. Each one calls for a customized strategy and distinct trial management approach. Covance develops fit-for-purpose solutions Designed Around You® that enable more efficient clinical trials and focus on what is most valuable to your organization.
Supporting Individuals with Intellectual and Developmental Disability During the First 100 Days of the COVID-19 Outbreak in the U.S.
BrightSpring Health Services Chief Medical Officer Dr. William Mills presents on BrightSpring's ongoing response to COVID-19 and how the organization is mitigating risks for our patients, clients, and team members.
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Cell & Gene Therapy Post-Approval Solutions
1. Supported the development of
BOTH
GENE
REPLACEMENT
THERAPIES
FDA approved
CAR-T therapies and helped
advance the first 2 FDA-approved
Real-World Evidence Studies
& Post-Marketing Commitments
Long-term follow-up studies
Disease and product registries
Global presence; deep therapeutic area expertise
~25 Project Managers
Database of 200,000 physicians worldwide
Contacts with regulatory and payers in
key markets
Access to policy, fee schedule payment data
and decision makers
Patient Safety & Pharmacovigilance
1,300+ safety professionals across the U.S., Europe and Asia Pacific
200+ person team of highly experienced safety writing professionals
120+ member team of medical reviewers–case review, aggregate
review and signal management
PV SMEs available locally in each region to provide guidance in
global and local regulations
CELL & GENE THERAPY
Post-Approval Solutions
With specialized expertise, coordinated capabilities and focused
investments across preclinical, clinical and post-approval phases, we’ll help
you to reduce the time and risk in your product’s development.
Processed
in the last
5 years
From intake
and case
processing
automation
Regulatory compliance
achieved in the last 4 years
~2.5M 55% >99.5%
CASES TIME
SAVINGS
Across all product & therapeutic areas