FSP Integrated Solutions

Data management

Our data operations experts efficiently and accurately manage clinical trial data throughout its lifecycle. This includes data collection, processing, validation, analysis and reporting. The team ensures that data is captured in a standardized and reliable manner, adhering to regulatory requirements and industry best practices.

The data operations team collaborates closely with sponsors, clinical operations teams and other stakeholders to develop data management plans, establish data standards and implement data capture strategies. They are responsible for setting up electronic data capture systems, developing data validation checks and cleaning the data to ensure its quality and integrity.

Medical writing

Our medical writing team works closely with you to create high-quality, well-structured and scientifically accurate documents that support your clinical development and regulatory strategies.

Our team includes roles such as associate medical writers, senior medical writers, document quality reviewer, principal document quality reviewer, document specialist, lead document specialist and medical writing support coordinator. 

This collective team handles everything from document writing and preparation for product development, approval and commercialization to authoring, medical writing project management, trial disclosure and publishing.

Regulatory

Our global regulatory colleagues (including regulatory affairs managers, compliance experts and project managers) provide expertise across a range of outsourced regulatory solutions, including regulatory dossier compilation, publishing and dispatch, clinical trial applications, centralized CMC and labelling and post-approval submissions and lifecycle management. We also partner with clients on project-based deliverables including regulatory strategy, market authorization submissions, M&A license transfers and RIM – data entry, data cleansing and data migration. 

We work with clients on asset-based outsourcing, often for mature products or low-risk portfolios or on a functional basis for activities like CMC, labeling or publishing. Services are delivered by a unitized (deliverable) model, or an FSP (dedicated FTE) model.

By outsourcing and consolidating non-core regulatory activities, our experts can ensure your regulatory team focuses on core business activities and your development pipeline.

Pharmacovigilance

Our pharmacovigilance function serves to ensure the safety and well-being of patients participating in clinical trials. Our PV team is responsible for the efficient collection, evaluation, and reporting of adverse events and other safety-related information to the relevant regulatory authorities. We comply with global regulatory guidelines and industry standards to ensure the highest level of patient protection.

Through close collaboration with our FSP partners, we establish and maintain robust safety management plans, develop standard operating procedures, and conduct thorough safety trainings.

Translational medicine

Our translational medicine group – comprised of scientific directors, biomarker sample management specialists, biomarker sample operations associates and precision medicine associate directors – conceives and implements data-driven, target therapy development strategies to deliver novel therapies that treat patients based on their unique genomic and biomarker characteristics. Our genomic medicine scientists apply expertise, innovation and state-of-the-art methodologies in the strategic and operational implementation of genomics and biomarker services to help clients:

• Better understand the genetic/genomic basis for the disease, drug, target and pathway
• Differentiate drugs from competitor medicines in development or on the market
• Stratify drug responders/non-responders and enrich clinical trial design
• Develop biomarker and companion diagnostics strategies
• Inform the benefit-risk profile of personalized medicine