AREAS COVERED
What We Do
Our Full Service CRO
REGULATORY APPROVALS
It is difficult to overestimate the importance of local knowledge of the regulatory requirements while performing study regulatory support.
Different countries have different regulatory pathways and timelines – some countries require both National and Local Ethics Committees / Institutional Review Board (IRB) approvals, some require Local Ethics / IRB approvals before national submission
REGULATORY APPROVALS
It is difficult to overestimate the importance of local knowledge of the regulatory requirements while performing study regulatory support.
Different countries have different regulatory pathways and timelines – some countries require both National and Local Ethics Committees / Institutional Review Board (IRB) approvals, some require Local Ethics / IRB approvals before national submission
SITE SELECTION
The goal of project management is to ensure a smooth project performance with no disruptions.
We realize that proper planning is the cornerstone of every project, and we put special emphasis to the development of and adherence to project plans, such as the study-wide Project Plan, Communication Plan, and Risk Management Plan.
SITE SELECTION
The goal of project management is to ensure a smooth project performance with no disruptions.
We realize that proper planning is the cornerstone of every project, and we put special emphasis to the development of and adherence to project plans, such as the study-wide Project Plan, Communication Plan, and Risk Management Plan.
TRANSLATION AND VALIDATION
Conducting studies in more than one country and in more than one language is now par for the course, but translation is a multifaceted affair. Equality and diversity in clinical studies is vital: it doesn’t make sense for a patient who presents perfectly for a trial to be turned away because they don’t speak English.
TRANSLATION AND VALIDATION
Conducting studies in more than one country and in more than one language is now par for the course, but translation is a multifaceted affair. Equality and diversity in clinical studies is vital: it doesn’t make sense for a patient who presents perfectly for a trial to be turned away because they don’t speak English.
DATA MANAGEMENT AND STATISTICS
CONFIDENCE Clinical Data Management and Statistics adhere to all the applicable standards, laws and guidelines of quality and truthfulness in scientific research. Our Data Management and Statistics specialists are involved in project planning from the start, work with other functional groups, and are part of all relevant study decisions.
DATA MANAGEMENT AND STATISTICS
CONFIDENCE Clinical Data Management and Statistics adhere to all the applicable standards, laws and guidelines of quality and truthfulness in scientific research. Our Data Management and Statistics specialists are involved in project planning from the start, work with other functional groups, and are part of all relevant study decisions.
MEDICAL WRITING AND SAFETY
It’s critical to have a well-formulated Study Protocol which outlines the program’s scientific goals and has a deep understanding of the therapeutic field, justified sample size, meaningful inclusion/exclusion criteria, and clearly stated procedure requirements, while meeting the requirements of a highly regulated field.
MEDICAL WRITING AND SAFETY
It’s critical to have a well-formulated Study Protocol which outlines the program’s scientific goals and has a deep understanding of the therapeutic field, justified sample size, meaningful inclusion/exclusion criteria, and clearly stated procedure requirements, while meeting the requirements of a highly regulated field.
BUSINESS CONSULTANCY
We can help entrepreneurs at every stage. With over 30 years of hands-on experience in the field, when it comes to giving clear, impartial and constructive feedback, we know what we’re doing – and as your company grows, we know what you should be doing too.
BUSINESS CONSULTANCY
We can help entrepreneurs at every stage. With over 30 years of hands-on experience in the field, when it comes to giving clear, impartial and constructive feedback, we know what we’re doing – and as your company grows, we know what you should be doing too.
Why us?
Game Changers with Confidence
Benefits of a Global CRO without Costs and Bureaucracy
- Global Reach
- Full Service
- Flexibility of a human size CRO
- Client oriented/project centric culture
- Lean Management Approach: low overhead, lowers costs
Collaborative Risk Management Strategy
- Planning and risk management – no firefighting
- Risk sharing: bonus-and-penalties system for project milestones