Case Study: ethica Clinical Research Inc.
Mindprint provided ethica Clinical Research Inc.

with a complete ERP solution to manage all processes

BUSINESS SITUATION

Complete Automation Required: for easier Management

ethica conducts clinical research for major pharmaceutical leaders worldwide and their complex projects schedules range from a few weeks to multiple years. The complex nature of ethica’s client contracts, complex projects, and a dynamic travel schedule of ethica’s consultants, created a number of data management challenges. Information resided in various formal and informal databases and information from various sources was being consolidated manually for monthly invoicing.

ABOUT ethica CLINICAL RESEARCH Inc.

ethica Clinical Research Inc. is a full-service Contract Research Organization (CRO) that conducts and manages ethical clinical research on drugs, biologics, medical devices and natural health products.

ethica is celebrated in becoming the first Canadian entity and the first CRO in the world to become accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP)

CHALLENGES

  • The prime challenge was to create the ideal processes that would fit the size and culture of ethica.
  • Another challenge was to ensure that the system allowed for the rich and complex nature of ethica’s contracts with their clients, including payment terms and schedules that were tied to multiple events and triggered based on project milestones.
  • Data migration of all the master data and transaction data of all the projects for the last one year
  • To implement the solution onsite and Go-live in the time-frame of four months.

TECHNOLOGY AND TOOLS

  • Axpert
  • Axpert.NET
  • Oracle 11g
  • Intelliview
  • Microsoft Remote App
  • Microsoft Windows Server 2008
  • Microsoft Office

SOLUTION

  • Fully designed and developed Axpert modules were used for development and implementation.
  • A complete business solution comprising the following modules and features, was implemented
  • CRM – covering Lead, Client management, Doctors, and Clinical Research Sites.
  • HR – covering Employee Information Repository, Vacation and Sick Day Requests, Quota Management.
  • Pre-Sales – including Project Estimation, Quotation, Client Payment Schedules, Client Contracts.
  • Operations – including Project Creation, Staff Assignment, Milestone Management, Timesheets, Research Site Monitoring Sheets, Expense Management.
  • Invoicing – Multi-currency Invoice Generation
  • Accounting – Interfacing with Quickbooks
  • Reporting – Profitability By Study/Client, Revenue Forecasting, Quote Expiry, Timesheets, Resource Availability, etc.

BENEFITS

  • Comprehensive yet simple-to-use solution provided facilitating easy access to employees without adding unnecessary processes
  • Instant and real-time availability of Graphical MIS reports providing total business condition visibility thereby enabling informed, timely and effective decision-making.
  • Improved productivity and better utilization of resources.
  • Real time sales and sales pipeline data.
  • The cost of maintenance is very low and hence better Return Of Investment.
Case Study: Ockham Oncology
Ockham implements Leading-edge automation system from Mindprint Inc.

 

Why Profitability Analysis is Challenging for CROs

It would seem like a simple matter for a CRO to figure out the profitability of any particular study it undertakes. The reality is that this is one of the most difficult—but important— aspects of the business.

The problem is that pharma companies which outsource studies to CROs, employ a so-called unitized method of setting an overall budget. The scheme works something like this: the pharma company pays the CRO for each unit delivered. It is up to the CRO to estimate accurately ahead of project start how much time each professional—whether clinical research associate, project manager, quality analyst, or others—will need to spend in order to produce the deliverable regulatory document, which is called a ―unit.‖ If it turns out that the CRO underestimates the actual time required by the various professionals on the project to create a deliverable unit, then profitability goes down. If certain units are consistently exceeding the estimated time, the budgeting system must be fine-tuned to ensure future profitability. This crucial aspect of the CRO business is handled automatically by the Mindprint software, ensuring much more accurate profitability analysis.

BUSINESS CHALLENGE

It was a good problem to have. Expecting only about a dozen or so new clinical trials in the next few months, Ockham, a leader in the field of oncology services, suddenly saw its new contracts jump more than five-fold. Having recently acquired a contract research organization (CRO) in Scotland, and, before that, a US-based CRO, Ockham’s business was growing quickly—but not without some growing pains.

Even before the acquisitions and growth spurt, Ockham, which provides a full range of services to pharmaceutical companies—from providing top-notch research staff, to managing and conducting end-to-end cancer therapy clinical trials—Ockham faced a big challenge in finding the right software tools to manage the lifecycle of its Clinical Studies.. The company, based in Cary, North Carolina, chose Toronto-based Mindprint Inc. for a company-wide professional services automation (PSA) system that promised to make the entire company more productive and profitable.

―We have completed more than 250 clinical trials for new cancer therapies,‖ explains Jim Baker, founder and CEO of Ockham. ―But one of our biggest challenges was measuring the profitability of each study, simple as that may sound. We just didn’t have the right tools in place to do that consistently and accurately.‖ Baker added that integrating the data systems of the new acquisitions was also a challenge that required a new set of tools.

Mindprint, which specializes in enterprise software for CROs, was nearing deployment of Ockham’s new custom system—when news of the sudden spurt in business came in. ―We had to move quickly to import a large number of studies into the system,‖ explains Prasad A. Sristi, founder and CEO of Mindprint. ―But we were able to quickly redesign a core part of the system to allow for the importation of a large number of new projects, and make the system much more scalable. We turned a challenge into an opportunity.‖

For Ockham, the business challenges caused by the outdated software, quickly turned into formidable new tools for business growth and profitability. ―We work seamlessly across four continents now,‖ notes Baker. ―Our staff is more effective, our clients are happier, and we are on a sound growth path.‖

TECHNOLOGY

The technology that made all this possible is an innovative platform called Axpert, developed by Bangalore, India-based Agile Labs. The patented Axpert system is based on a method of rapidly creating custom enterprise software – without expensive and time-consuming programming.

“Axpert makes application development and maintenance easy, by substantially reducing the effort required,‖ explains Prasad Sristi, founder and CEO of Mindprint—which developed a large library of Axpert modules specifically for CROs. ―Application development using Axpert requires only domain experts. No expensive coding is required.”

SOLUTION:

      • Fully functional Professional Services Automation (PSA) system—a single operational system to run the entire company.
      • Fully scalable solution that will allow the software system to continue to grow with the company
      • Core functionality comprising the following capabilities:
      • Study Proposals: built-in flexibility, allows customizable proposals for each client’s unique requirements, with risk-free, fixed-bid, engagement model.
      • Study Management: includes automated staffing, timesheet and expense report generation.
      • Revenue Forecasting: using business intelligence technology that can be fine-tuned by user input. No programing required.
      • Resource Planning: allows Ockham to align their professional resources with the client’s exact needs.
      • Invoicing: highly automated invoice generation cuts invoicing time, allows for high level of individual client personalization
      • Customer Relationship Management (CRM): includes client management, lead generation, and site report generation.
      • Human Resources (HR): automated expense reports, vacations, and sick days.

BENEFITS

        • Entire company working on a single & simple-to-use platform. Excellent scalability and low training requirements.
        • Much more accurate financial data. No mis-reported units and returned invoices
        • Accurate financial forecasts for the entire company. Senior management can look into the next 12 months of expected cash flow with the click of a single button
        • More discipline in budgets. Ockham team is able to churn out dozens of budgets from our system every month.
        • Invoicing time cut down drastically
        • High visibility into profitability. Study profitability is measured down to each unit based on the salary of employees actually working on those units.
        • Decreased administration overhead costs. Ockham can quickly start operations in a new country or geography.