High-Quality Regulatory Submissions

Clinical Trials >> Compliance, Regulatory & Consulting >> Regulatory Affairs

Quotient has an in-depth understanding of the evolving clinical trial regulatory environment in Europe and the U.S., ensuring the production of high-quality dossiers and a seamless submission and approval process for Phase I clinical trial application.

In Silico Modeling & Simulation

Clinical Trials >> Compliance, Regulatory & Consulting >> Clinical Trial Design

We provide in silico modeling and simulation for all our formulation design and selection programs. Our experts use GastroPlus™ to model physicochemical, biopharmaceutical and pharmacokinetic data, providing valuable insight into the in vivo performance.

Investigator Training & Support

Clinical Trials >> Compliance, Regulatory & Consulting >> Training

If investigator training meetings are required, LabConnect will send a PM to your investigator training meetings in the regions you designate. A detailed laboratory manual will be developed based on the protocol and may be translated upon your request.

FDA Regulatory Strategy

Clinical Trials >> Compliance, Regulatory & Consulting >> Quality & Compliance

Factory’s team has a broad and in depth knowledge on FDA requirements and procedures and can help you design a regulatory strategy specific for your device.

Interaction with Regulatory Agencies World-Wide

Clinical Trials >> Compliance, Regulatory & Consulting >> Regulatory Affairs

The TFS Global Clinical Development Team provides strategic advice on clinical development. TFS’ team of specialists in clinical development, early phase development, regulatory affairs, and medical experts in a broad range of therapeutic indications support our customers in their clinical

Product Development Consulting

Clinical Trials >> Compliance, Regulatory & Consulting >> Consulting Services

The TFS Global Clinical Development Team provides strategic advice on clinical development. TFS’ team of specialists in clinical development, early phase development, regulatory affairs, and medical experts in a broad range of therapeutic indications support our customers in their clinical

Pragmatic / Adaptive Studies

Clinical Trials >> Compliance, Regulatory & Consulting >> Consulting Services

Pragmatic studies aim to quantify the risks, benefits and costs of an intervention in routine clinical practice, often helping to inform how a treatment may be applied by clinicians outside of the clinical trial environment.

Clinical Development Strategy

Clinical Trials >> Compliance, Regulatory & Consulting >> Clinical Trial Design

DZS Clinical Services provides expert consultation and advice on the strategic direction of your clinical trial for your drug product or device across many therapeutic areas in the biopharmaceutical, medical device and government and nonprofit sectors.

Market Access

Clinical Trials >> Compliance, Regulatory & Consulting >> Consulting Services

Our expert teams of industry leaders, former payers, policy experts, and experienced strategists can help you navigate complex evidence requirements and anticipate and overcome payer barriers to help you achieve optimal price and access.

Quality Assurance

Clinical Trials >> Compliance, Regulatory & Consulting >> Quality & Compliance

When contracting with LSR Trials, you can be assured that we will meet all deadlines and the data will be immaculate to ensure a successful trial.