Consulting

CONSULTING

Consulting and Advisory Services

Advisory services and consulting across all phases of drug and device development

As a full-service global contract research organization, we provide consulting on a variety of topics, including Regulatory & Compliance Affairs and Medical Affairs. We also provide strategic analysis to support improved decision-making in drug and device development.

We provide deep subject matter expertise over the entire lifecycle of an organization, portfolio or asset and our unique ability to leverage end-to-end capabilities and global functional and therapeutic experts results in highly customized solutions. Deep pre- and post-launch expertise generates strategic insights that yield implementation-focused recommendations designed to reduce risk, speed time to market and increase overall asset and portfolio value.

Regulatory Affairs

Working together, our regulatory consulting services empower you to maintain control of your pathway and stay ahead of any compliance risks. With practical interpretation, we help you understand how guidelines around the world apply to you.

Regulatory Strategy & Development Planning

GxP Compliance

Regulatory Outsourcing

Clinical Trial Regulatory Services

REMS and Risk Management

CLINICAL DATA MANAGEMENT

When it comes to clinical development, we’re dedicated to getting every moment right. And we have the people to get you there. The seasoned advisors on our Regulatory Consulting Services team have decades of experience helping teams interpret new and existing guidance throughout the process – and throughout the world. In fact, many of them are former FDA, EMA, and NMPA regulators themselves.

Non clinical and Pre-clinical development

Due diligence and asset valuation

Value and evidence communication

Medical device consulting

Research and Development

Commercial Advisory Service

Portfolio Strategy and Transactions

Health Economics and Outcomes Research

Product and Franchise Strategy

Value and Access

Customer and Digital Engagement

Global pricing and market access strategy

(Please also refer to our post-marketing solutions)

Scientific and Medical Affairs Advisory Service

We can connect you to the know-how you need with customized medical liaison programs. In many cases, our Medical Science Liaisons, Clinical Trial Liaisons, Clinical Specialists, Managed Care Liaisons, and management and training personnel act as an integral part of our client’s teams. These seasoned advisors enhance the exchange of scientific information between your organization and the medical community, no matter your size.

Medical Science Advisory

Medical Science Liaisons are doctoral level and advanced degreed healthcare professionals acting as regional extensions of your medical affairs departments. They engage with a wide range of HCP stakeholder audiences answering their clinical questions about your drugs/devices and the diseases those treat.

Clinical Trial Advisory

Qualified to doctoral level and advanced degreed healthcare professionals, our Clinical Trial Liaisons support your clinical trial needs. Each CTL is focused on providing awareness of a clinical trial, ultimately resulting in increased patient enrollment for your trial. They possess strong backgrounds in clinical research and clearly understand the clinical development process.

Clinical Specialists

Each Clinical Specialist on our team are credentialed professionals that work on behalf of you, providing regional and community level HCPs with educational support, including in-services, technical training and clinical reinforcement messaging. Our CSs are regional and local extensions of our clients’ medical affairs departments and closely collaborate with their commercial teams.

Managed Outcomes Advisory

Managed Outcomes Liaisons are doctoral level healthcare professionals with expertise in public health and/or outcomes. Each MOL aims to convey the clinical utility of our clients’ drugs and support the value proposition as to why these drugs should be utilized by payers and their members.

Clinical Nurse Educators

Clinical Nurse Educators are deployed to address a specific gap for a product where utilization, adherence, or uptake is limited or challenging. Through peer-to-peer discussions with target HCPs and Nurses, CNEs can provide hands on training for products, devices and education on the disease management tools used to diagnose and treat chronic conditions.