<img height="1" width="1" style="display:none" src="https://www.facebook.com/tr?id=259446424624044&amp;ev=PageView&amp;noscript=1">

Fullscope Blog

A real-world look at digital transformation.

A Top 10 Software Features List for Drug Development Companies in Phase 3 Trials

By Connie Keasler | August 30, 2018

Drug development costs range from $10M to $2B. According to the Huffington Post, it cost >$1B to develop the blockbuster drug Lipitor. To properly account for and allocate the costs, drug development companies – especially in phase 3 trials – need robust financial software. Robust financial software costs more money. The hardware and information technology staff costs more money – so you need to consider the right technology. The financial software needs to support easy integration of auxiliary software, like clinical trial software. If phase 3 results are promising, drug developers need additional best practice enterprise software to ramp up efficient manufacturing and remain FDA compliant.  Here is a top 10 list for phase 3 trials when considering ERP software:

1. Economics

Financial applications available in the cloud are like utilities – pay only for what you use.  The apps are accessible from a browser and on mobile devices, eliminating the need for large-scale data centers. 

2. Speed

With cloud computing comes more storage space, computing cycles and updating software takes minutes instead of days, weeks or months. Time-to-market acceleration and personalized application adaption, with no-code visual editors and tools, make it fast and easy to build and deploy web and mobile apps. 

3. Scale

As a pharmaceutical organization moves through the trial phases and into manufacturing, the financial software vendor should offer a robust Enterprise Resource Planning (ERP) solution. They need to have the ability to scale from a simple solution for clinical trials to a robust solution, in order to handle more complex requirements for manufacturing and distribution. Pharma companies with a large number of users on-premise or in the cloud should be using this type of software. 

4. Ease of Use

Select software that is familiar to the user with role-based screens, dashboards, Excel integration and Microsoft Office 365 plugin capabilities. Make sure that the software is easy to personalize without programming, so solutions are easy to tailor to meet specific needs. 

5. Ease of Integration

Drug development companies need auxiliary software during the years of development to the shelf.  The selected platform should support core functions for productivity, communications, relationship management, and analytics, as well as have the capability to support technologies from multiple cloud providers and device manufacturers. 

6. Security

The financial and total enterprise software must have certifications to show it complies with and supports health, security and privacy regulations in multiple countries. The software industry experts who manage cloud data centers should take physical, technical and operational measures to achieve and maintain security, privacy and regulatory compliance. In addition, they must also be able to immediately deploy the latest security patches automatically. Use a single regulatory format for multiple software versions, and enable users with a no‑code configuration approach to change regulatory reports, e-invoices, payment formats and tax rules. 

7. Vendor Experience and Knowledge

Select a software vendor with pharmaceutical expertise and knowledge that spans from phase 3 trials through manufacturing. Because of the additional regulations, it is critical that the software vendor understands the requirements and can help the customer navigate the regulations. Select a software vendor with an experienced staff and loyal customers. 

8. Streamlined Procurement

Automated procure-to-pay processes reduce procurement costs and increase cost control. 

9. Reduce Operational Expense

Minimize operational costs across business geographies with financial process automation, encumbrance, budget planning, budget control and three-way matching. 

10. Cost Accounting Functionality

The following cost accounting capabilities are required: 

  • Conversion of the information from financial management into cost data. 
  • Comparison and reconciliation of chart of accounts with cost categories.
  • Cost-based regulation and cost reallocation, where necessary, with a context overview without any modification of G/L entries.
  • Analysis of the entire cost flow.
  • Cost allocation on the basis of consumers or cost rates.
  • Flexible, easy-to-use allocation schemes.
  • Parallel versions of cost analyses for actual, projected, simulated or future strategies.
  • Fulfilment of all requirements for analytical and consolidated reporting. 

Download this whitepaper to learn how pharma companies can take advantage of the cloud while keeping their system secure and FDA compliant. 

New call-to-action

 

About Connie Keasler

Connie has over 25 years of experience in the ERP software industry. She connects daily with manufacturing executives sharing and exchanging information on how digital transformation helps companies achieve the best business outcomes.

Comments

Latest Posts