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Key Highlights

  • New drug discovery is a long-drawn process involving significant investments and uncertain returns. From drug discovery to development, getting approvals and putting it out in the market requires allocating appropriate resources and managing the budget. Using an automated solution can help anticipate costs, reduce waste, and improve ROI.
  • A Clinical Budget Management Solution can help with budget definition, forecasting, and tracking and scenario planning. The activity-based costing model lets you define costs at study or site level – tasks and procedures.

Introduction

Bringing a new drug to the market is an expensive affair. Here is some data to ponder over: it costs $2.6 billion on average to develop new drugs, less than 12% drugs enter clinical development, and the whole process can take 10 to 15 years from discovery to launch.

Though the number of new drugs being introduced every year has gone up, with an average of 50 approvals annually, the ROI is declining.

Clinical trials are a crucial part of drug development as they demonstrate the safety and efficacy of a new drug, improve the capabilities of a known drug, establish superiority among similar drugs, etc. According to a Business Wire report, the global clinical trials market size is expected to grow at a CAGR of 5.7% from 2021 to 2028 to reach USD 69.5 billion by 2028.

Budget Management is a critical requirement

Clinical trial budgeting plays a pivotal role in meeting financial objectives and driving operational efficiency for the following reasons:

  • Ever-increasing costs of clinical trials
  • Increasing complexity of processes
  • Multi-vendor outsourcing partnerships
  • Decrease in federal funding
  • Stakeholder expectations on reducing the overall trial costs

Budget management is critical for clinical trial planning and execution and must ideally address two key objectives:

  • Allocation of sufficient amount throughout the study, from startup to close out.
  • Recognizing what needs to be billed as research-related and what comes under the insurance or standard of care.

A centralized automated solution to handle budgeting aspects such as billing and administrative functions is becoming important to increase productivity and ROI.

At ComplianceQuest, we recently published a whitepaper on why automation of the Clinical Budget Management Process will really help. The paper covers several important topics including best practices, common challenges in budgeting, and how to streamline collaboration among various stakeholders.

Click here to read this whitepaper

Key challenges in budgeting of clinical trials

Budgeting done through spreadsheets is tedious, especially when reconciliating all the budgets for different trials and multiple sites. Delay in timelines is largely due to the lack of a standard template followed for budgeting. Payments and receipts that are generated manually can cause a mismatch in the amounts leading to rework for the billing staff.

Budgeting for clinical trials can be a complex process with a lot of unknowns and variations that need to be properly accounted for and managed as assumptions. The following are the top challenges in the budgeting process for clinical trials:

  • Timeline delays
  • Legacy systems
  • Lengthy negotiation process
  • Complexity in outsourcing
  • Lack of Integration between various systems
  • Unscheduled events
  • Trial complexity
  • Lengthy submission timelines

Clinical budget management solution

CQ Clinical Budget Management solution is an integrated, end-to-end solution to help all the stakeholders, sponsors, CROs and sites gain visibility, control, and flexibility across clinical trial projects. The solution helps in accelerating study budget management with a high level of accuracy with a faster cycle time. Budget management is based on activity-based planning with the ability to define budget templates based on in-house research, outsourced or both, and also support study-specific or site-specific budgets.

Budget definition, forecasting, and tracking are made easy to use and flexible to handle various scenarios. The activity-based costing model lets you define costs at study or site level tasks and procedures. The solution also enables auto-creation of payables and receivables for real-time visibility on actual costs as and when the events/tasks are completed at both the study or site level. CQ Clinical Budget Management solution provides the option to manage miscellaneous costs which could be incurred anytime during the trial.

The budget created can be easily shared, submitted, reviewed, and approved by any assigned authority, with an ability to set up process flows and an approval process with simple point-and-click steps. The solution provides complete audit tracking capability for compliance with details like what fields were changed on what date and by whom and so on.

CQ Investigator Portal, a single platform accessible anytime, anywhere and on any device, provides investigators and sites with easy access to budget and payment data for real-time collaboration.

A comprehensive solution for managing clinical trial budgets at every level, find out how the ComplianceQuest Budget Management solution can help you manage your clinical trial budgets better.

To know more about CQ Clinical Budget Management solution, contact us now:
http://www.compliancequest.com/clinical-trial-management-solutions/

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