Service Catalog

End-to-end capabilities for every stage of development.

Our core service offerings across Clinical Development, Regulatory, Safety, and Analytics — plus fractional executive leadership for teams that need physician-led oversight.

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Track A

Fractional Executive Advisory

Bring in founder-level clinical and technology leadership without full-time overhead.

Fractional CTO Advisory

eClinical architecture, AI governance, and trial technology operating models.

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Fractional CMO Advisory

Clinical strategy, protocol quality, and medical leadership for pivotal decisions.

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Track B

Full-Service Delivery

End-to-end services across Clinical Development, Regulatory, Safety, and Analytics.

Clinical & Regulatory Strategy

Protocol design, dose-escalation strategy, expedited pathways, health authority interactions, and NDA/BLA readiness — from IND to BLA.

  • Protocol design & dose-escalation strategy
  • Expedited pathways (Fast Track, RMAT, Accelerated Approval, RTOR, Orbis)
  • Health authority meeting preparation
  • NDA/BLA red-team review & inspection readiness
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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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AI Strategy, Vendor Evaluation & Governance

Use-case prioritization, a six-step vendor evaluation method, and a risk-tiered governance framework mapped to FDA, EMA, and ISO/IEC 42001.

  • AI strategy & vendor evaluation
  • Risk-tiered governance framework
  • eClinical architecture & integration
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AI-Enabled Delivery

Governed AI solutions across protocol authoring, data cleaning, document generation, biostatistics, and enrollment analytics — each with named human sign-off.

  • AI-assisted protocol authoring & document generation
  • Data cleaning & biostatistics automation
  • Feasibility & enrollment analytics
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Track C

Enablement for CROs, FSPs & AI Builders

The same clinical, regulatory, and AI-governance depth, packaged for the teams that serve sponsors — or build the AI sponsors use.

Emerging Biotech

Protocol design, regulatory strategy, and safety governance for lean, fast-moving teams.

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CRO & FSP Enablement

Modernization, staff credentialing, and sponsor-facing capability under your own brand.

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Expert-in-the-Loop

Named, credentialed reviewers who validate and sign off on AI output in regulated work.

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Detailed capabilities

Full Service Catalog Overview

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

Track B · Clinical

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. Learn more about our KOL & Expert Network →

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.
Track B · Safety

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.
Track B · Regulatory

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.
Track B · Therapeutics

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.

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