1200 +

Employees Globally

60 +

Countries Served

9

Legal Entities

20 +

Country Registrations

$ 160 M

Annual Revenue (2025)

  • Overview

A Science-First Global CRO Navigating Complexity at Scale

This customer is a globally established Contract Research Organization (CRO) delivering comprehensive, end-to-end clinical development services with a specialized focus on small and mid-sized biopharmaceutical companies. With a high-touch partnership model, the organization supports sponsors from early preclinical development through late-phase clinical trials, regulatory submissions, and post-marketing pharmacovigilance.

Operating across the United States, Canada, Europe, and Australia — and registered in more than 20 countries — the organization manages an exceptionally complex multi-entity structure spanning nine legal entities. This geographic and structural diversity demands rigorous financial controls, standardized billing workflows, and seamless cross-entity collaboration at every stage of clinical project execution.

A science-centric, agile operating model built on integrity and client collaboration — driving novel therapies from concept to regulatory approval, efficiently and compliantly.

With a customer base extending across more than 60 countries and a team of 1,200–1,500+ professionals, the organization required an enterprise platform capable of unifying project accounting, multi-entity invoicing, intercompany transactions, and real-time financial reporting — while meeting the compliance standards of clinical research and pharmaceutical regulation. Annual revenue for 2025 is reported at $160.5 million.

The organization provides end-to-end drug development services including preclinical and early development support, clinical trial management, regulatory strategy and submissions, clinical pharmacology and translational sciences, biometrics and data sciences, drug safety and pharmacovigilance, government and public health research, and specialized therapeutic area expertise.

  • Oncology
  • Rare Diseases
  • Neuroscience
  • Cell & Gene Therapy
  • Infectious Diseases
  • Pediatric Trials
Core Services

Full-Spectrum Clinical Development Capabilities

The organization provides a fully integrated service portfolio spanning every phase of clinical drug development, structured around dedicated Centers of Expertise to handle complex trial designs across multiple therapeutic areas. Its services extend into post-marketing support and pharmacovigilance, along with significant expertise in pediatric clinical trials ensuring ethical, age-appropriate study designs.

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Clinical Trial Operations

Full-service management covering site selection, study start-up, patient recruitment, monitoring, and study close-out across early- to late-phase studies.

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Regulatory Affairs & Strategy

Regulatory submissions, compliance management, and coordination with health authorities for approvals, including post-marketing regulatory strategy.

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Clinical Pharmacology & Translational Sciences

Regulatory submissions, compliance management, and coordination with health authorities for approvals, including post-marketing regulatory strategy.

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Biometrics & Data Sciences

Clinical data management, statistical analysis, and validation using advanced methodologies to ensure regulatory-ready, integrity-verified outputs.

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Drug Safety & Pharmacovigilance

Adverse event monitoring, safety analysis, and regulatory safety submissions — from clinical trials through post-market surveillance.

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Decentralized & Hybrid Trials

Patient-centric trial solutions integrating decentralized and hybrid design models, with dedicated support for pediatric clinical trials with ethical protocols.

Explore Our Clinical Development Expertise
Business Functions

5 Core Business Functions Powering D365 Operations

Across its nine legal entities, the organization runs tightly coordinated internal business functions that span customer onboarding, project management, time tracking, pricing, and financial billing — all executed through Microsoft Dynamics 365 Finance & Operations.

01

Customer Onboarding

Each engagement is structured at the individual clinical site level, with every site treated as a separate unit. The commercial team records customer information, contract scope, and preliminary costing in Salesforce. Once finalized, details transfer to Dynamics 365 for operational setup — ensuring each site engagement is clearly defined before project creation.

02

Project Setup & Structure

A separate project is created in Dynamics 365 for each clinical site. A header project (internal type) acts as the parent, with subprojects organized as: hours logged by employees (.01), pass-through expenses (.02), Investigator Grants and Fees (.03), project-related service fees (.04), and advance invoices (.05). Three project types are used: Internal, Fixed Price, and Time & Material.

03

Time Tracking & Resource Utilization

Employees record timesheets against the relevant project subproject (.01) using standard Dynamics 365 timesheet functionality. The system supports intercompany timesheet postings — allowing staff from one legal entity to log hours against projects of another — enabling accurate cross-entity cost allocation and project billing.

04

Pricing & Cost Management

Each employee is assigned a Role ID with a standard hourly cost rate for internal monitoring. Pass-through expenses — including travel and operational costs — are tracked via expense reports on an actual basis. Hourly sales prices are defined per project–resource combination, aligned with customer contract terms. Pricing is maintained per legal entity to support cross-entity execution.

05

Project Financial Management & Billing

Contracts are executed across nine legal entities, with invoices issued from the entity responsible for project delivery. Revenue is recognized per contract terms. Dynamics 365 also maintains financial records and documentation submitted to regulatory authorities. The project hierarchy links every billing event to its cost category — hours, expenses, grants, or fees.

Business Processes

End-to-End Clinical Operations: Aligned Process Areas

The organization operates across twelve aligned business processes spanning the full lifecycle of clinical drug development — from business development through knowledge management and sponsor reporting.

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Business Development & Client Engagement

Identifying pharmaceutical and biotech clients, preparing proposals, negotiating contracts, and onboarding sponsors for clinical development projects.

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Project & Program Management

Planning, executing, and overseeing clinical development programs including scheduling, budgeting, resource allocation, and sponsor coordination.

Clinical Trial Operations green Clinical Trial Operations
Vendor & Clinical Site Management

Selecting, contracting, and managing third-party vendors and clinical sites involved in trials, including investigator grant and fee tracking.

Clinical Trial Operations green Clinical Trial Operations
Financial Management & Billing

Managing project budgets, vendor payments, sponsor invoicing, cost tracking, and financial reporting across nine legal entities.

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Medical & Scientific Consulting

Providing expert guidance on clinical development strategies, protocol design, and scientific documentation for sponsors.

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Quality Assurance & Compliance

Ensuring adherence to regulatory standards and clinical research guidelines through audits, quality management, and master data change logging.

Technology Stack

A Microsoft-Led Enterprise Architecture

The technology landscape is anchored by Microsoft Dynamics 365 Finance & Operations, serving as the core ERP for financial management, project accounting, and multi-entity operations. Within D365, the Finance (F&O) module covers AP/AR, general ledger, foreign currency revaluation, ledger calendars, tax reporting, and expense report management. The D365 Project module handles project timesheets, invoice proposals, intercompany AR/AP invoices, and project credit notes.

  • Dynamics 365 F&O

    Core ERP · Finance & Project

  • SAP Concur

    Expense Management

  • Veeva Vault

    Investigator Grants & Invoices

  • Salesforce

    Business Development & CRM

  • ADP / ARMS

    HR & People Management

  • SharePoint Online

    Content & File Distribution

  • Microsoft Graph

    Email Transport & Notifications

  • Project 360 by HSO

    ISV · Project Transactions

  • SecureD365

    ISV · Security & SoD Monitoring

  • BlackLine

    Financial Consolidation & Bank Recon

  • Power BI

    Business Intelligence & Reporting

  • Microsoft/Core

  • Third-Party Integration

  • ISV Solution

Integrations

A Connected Ecosystem Centered on Dynamics 365

Microsoft Dynamics 365 F&O serves as the central integration hub for all financial and operational data flows. Real-time and near-real-time data exchange with specialist platforms ensures every business activity — from investigator invoice approvals to employee expense reports — is captured, validated, and posted without manual intervention.

Key Flow

Power BI reports are deployed across management levels providing real-time visibility into missing timesheets, AR ageing data, posted timesheets, and user efficiency data — all sourced directly from Dynamics 365.

See How We Connect Complex Clinical Ecosystems
Customizations & Extensions

Purpose-Built Solutions Delivered by DynaTech Systems

To address the organization's unique requirements across multiple legal entities and regulatory contexts, DynaTech Systems delivered a series of high-scope customizations and platform extensions within Microsoft Dynamics 365 Finance & Operations:

Automation
Positive Pay File Generation (Bank of America)

Custom module producing BoA-compliant Positive Pay CSV files and distributing them securely via SharePoint, with automated failure notifications sent through Microsoft Graph.

Automation
EFT Automation for UK Legal Entity (LE-2110)

Automated electronic bank payment file generation for the UK entity, reducing manual intervention in the cross-border payment workflow.

Reporting
Statement of Account with Auto-Email & Failure Logs

Custom AR Statement of Account report with automatic email dispatch via Microsoft Graph and structured failure logging — replacing the Docentric reliance with a fully owned D365 Finance solution.

Automation
Vendor Remittance Advice Automation

Automatic dispatch of vendor remittance emails with failure notifications on send errors, eliminating manual remittance distribution across all legal entities.

Compliance
Master Data Change Log Framework

Audit-grade logging of sensitive vendor and customer master data field updates — including bank accounts, payment groups, payment terms, and Tax 1099 settings — for regulatory and internal compliance.

Reporting
Invoice Template Standardization

Consistent AR and AP invoice print templates standardized across all nine legal entities using D365 Finance Print Management, ensuring brand and compliance consistency globally.

Integration
SAP Concur Overage Expense Handling

Extended Concur integration to support separate reporting and posting of overage expenses, enabling finer billing granularity at the project subproject level.

Security
Process-Driven Security Role Redesign (SecureD365)

Complete overhaul of D365 security roles aligned to business processes, with AP month-end posting restrictions and Segregation of Duties monitoring via the SecureD365 ISV framework.

Entity Setup
New Legal Entity Configuration

Full configuration of two additional legal entities — Government entity (LE-1111) and Greece entity (LE-2445) — including intercompany postings, payment methods, check print with authorized signatory, and entity-specific reporting templates.

Automation
Vendor Invoice Posting Date Auto-Update

Automatic update of vendor invoice posting date on posting, ensuring accurate period allocation without manual correction by the AP team.

Project At a Glance

Microsoft Dynamics 365 F&O Implementation

Looking to unify complex multi-entity clinical operations on Microsoft Dynamics 365?

Talk to DynaTech Systems
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