Service Catalog

Our core service offerings across Clinical Development, Regulatory, Safety, and Analytics.

Four Pillars of Service

Our core service offerings across Clinical Development, Regulatory, Safety, and Analytics.

Clinical Development

We provide protocol design, clinical operations, site engagement and full trial management tailored for complex and rare disease programs.

  • Strategy & protocol design
  • Feasibility & site selection
  • Data management & biostatistics
  • Clinical operations & monitoring
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Regulatory

Regulatory strategy and submission support with deep experience interacting with global health authorities.

  • IND/CTA submissions
  • Regulatory writing & strategy
  • Labeling & lifecycle management
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Safety & Pharmacovigilance

Comprehensive safety monitoring, PV operations and risk management for modern therapeutic programs.

  • Signal detection & risk management
  • Aggregate reporting (PSUR/PBRER)
  • Regulatory inspection readiness
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Analytics & Data Science

From RWE to predictive models, we build analytics capabilities that enable faster, evidence-driven decisions.

  • RWE & observational studies
  • Predictive enrollment
  • Biomarker analytics
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Service Catalog Overview

A detailed overview of our end-to-end capabilities, designed to support biopharma innovators at every stage of the product lifecycle.

I. Clinical Development & Operations

End-to-end, expert-led services for the strategic design and global execution of your clinical trials.

Strategic Planning & Trial Design

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    Early Clinical Development Strategy: Guidance on dosing rationale, clinical pharmacology, and ethnic sensitivity for a robust early-phase plan.
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    Protocol Design & Writing: Physician-led development of scientifically sound and operationally feasible protocols to minimize amendments and delays.
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    Complex & Adaptive Trial Design Management: Expertise in a full range of modern trial designs, including First-in-Human (FIH) dose-finding, Bayesian dose escalation, two-stage cohort expansion, Basket and Umbrella trials, and seamless Phase I/II and II/III designs.
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    KOL & Investigator Consultation: Leveraging our network of renowned Key Opinion Leaders and Principal Investigators for insights on study design and clinical practice.

Global Trial Management & Execution

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    Feasibility & Site Selection: Dedicated feasibility department to identify and qualify the best trial sites globally for your specific protocol needs.
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    Patient Recruitment & Retention: Leveraging technology and relationships with patient advocacy groups to find and enroll eligible patients, with a focus on patient-centric practices to reduce burden and improve retention.
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    High-Touch Site Management: Providing expert guidance, education, and customized support to site staff, especially for complex trials like cell and gene therapies.

II. Pharmacovigilance & Safety Services

A full suite of scalable pharmacovigilance solutions to ensure patient safety and global regulatory compliance from clinical development through post-marketing.

Core Safety Operations

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    End-to-End Case Management: Processing of clinical trial SAEs, AESIs, pregnancies, and post-marketing cases (spontaneous, solicited, literature, social media). Includes intake, data entry, MedDRA/WHO coding, narrative writing, QC, medical review, and reconciliation.
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    Global Safety Database Solutions: Fully compliant and validated multi-tenant Argus safety database with options for read-only access or direct client access. Single-tenant and data migration solutions are also available.
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    Global ICSR Submissions: Timely submissions of ICSRs (MedWatch, CIOMS I, E2B) to health authorities, IRBs, and ECs worldwide, supported by our proprietary regulatory intelligence tool.
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    Global Literature Review: Systematic surveillance of worldwide scientific literature (e.g., Medline®) to identify reportable ICSRs and potential safety signals.

Advanced Safety & Risk Management

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    Signal Management: Expert-led signal detection, validation, prioritization, and assessment using data from spontaneous cases, clinical trials, and literature. Includes full support for EudraVigilance Data Analysis System (EVDAS).
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    Periodic Safety Reports & Aggregate Reporting: Authoring and submission of a wide range of aggregate safety reports, including PSURs/PBRERs, PADERs, and DSURs.
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    Risk Management Plan (RMP / REMS) Services: Preparation and maintenance of RMPs and REMS to identify, characterize, and minimize product risks for innovator, generic, and biosimilar products.
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    Medical Monitoring: 24/7 global medical monitoring, medical data review, and management of Safety Review Committees and Patient Surveillance programs. Includes a global emergency call service.

Specialized PV & Compliance Services

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    QPPV & Local PV Office: Provision of experienced and qualified EU QPPVs, Local Persons for Pharmacovigilance (LPPVs), and deputies in over 50 countries to ensure local and regional compliance.
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    Plaintiff Fact Sheet (PFS) & Medical Record Packet (MRP) Processing: A turnkey solution for processing high volumes of legal case documents, including data compilation, physician assessment, and reporting to health authorities.

III. Regulatory Affairs & Intelligence

Strategic guidance and tactical support to navigate the global regulatory landscape and optimize your path to approval.

Regulatory Strategy & Submissions

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    Regulatory Strategy Development: Shaping your regulatory pathway from the start, including support for Orphan Drug Designation applications in the US and EU.
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    Health Authority Interactions: Preparation for and attendance at regulatory meetings with agencies like the FDA, EMA, and MHRA.
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    Dossier & Report Authoring: Authoring safety content for regulatory dossiers, briefing materials, Clinical Study Reports (CSRs), and responses to Requests for Information (RFIs).
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    Expertise in Expedited Programs: Deep knowledge of special regulatory programs to accelerate development, including Accelerated Approval, Priority Review, Fast Track, Breakthrough Therapy, and RMAT designations.
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    Oncology-Specific Initiatives: Experience with innovative review programs like Real-Time Oncology Review (RTOR) and the international collaborative framework, Project Orbis.

Regulatory Intelligence

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    Proprietary Intelligence Tool: A comprehensive, internally developed database of global safety regulatory intelligence, offered as a value-add for PV clients.
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    Subscription-Based Intelligence Services: Tiered subscription options for non-PV clients, providing access to regulatory tables, expert interpretations, and direct consultant support.

IV. Core Therapeutic Expertise

Our services are underpinned by deep, physician-led expertise in complex and high-need therapeutic areas.

Oncology & Hematology

Extensive experience overseeing trials globally in both solid tumors and hematologic malignancies, with specific expertise in advanced modalities like CAR-T, Cell and Gene Therapies, and ADCs.

Rare Diseases & Pediatrics

Proven track record in over 210 rare disease studies, providing nimble, patient-centric solutions to address unique trial challenges, from protocol design to patient finding and retention.

Supportive Care in Oncology

Specialized management of treatment-related adverse events, including cancer breakthrough pain, cachexia, chemotherapy-induced toxicities, and immune-related adverse events (irAEs) like Cytokine Release Syndrome (CRS).

Additional Therapeutic Areas

Our clinical development expertise also extends to Dermatology, Cardiovascular diseases, and Ophthalmology, allowing us to support a broad range of innovative therapies.