Life Sciences

Why do so many clinical trials run late? How risk management helps trials deliver on time and to budget.

A critical challenge facing the life sciences industry is the need to improve operational efficiency in drug development. Given that clinical trials represent a significant proportion of the cost, and are a major element on the critical path of drug development projects, this is a major issue for all involved in the supply chain.

The sector acknowledges that almost no clinical trials deliver on time: contrast this with the situation for projects in other industries (e.g. defence and construction) where the proportion of projects delivered on time is considerably higher. With clinical trials growing larger and ever more complex, there is more and more pressure on organisations to conduct them more efficiently and effectively.

The complexities are increased when clinical trials are outsourced. Sponsors and contractors entering into contractual arrangements for such projects often fail to understand and address the inherent uncertainties and risks involved, and this can lead to major problems for all parties; including late delivery of contracted work and loss of profits.

CROs and CMOs are increasingly looking to risk management to meet these challenges and to develop a reputation with sponsors as the supplier of choice, while enhancing their profitability.  Sponsors are looking for suppliers who can prove their trustworthiness and can demonstrate they have a mature appreciation for the risks that might impact on their ability to deliver on time and to budget.

Predict!

The Predict! risk management software suite is unique in providing a tightly integrated combination of a multi-user web accessible central risk and action management database and a full function Monte Carlo analysis engine. Predict! supports proactive risk management at every stage of major projects and programmes, enabling organisations to gain competitive advantage.

Bid stage

  • Understand cost and schedule confidences to make informed “bid / no bid” decisions.
  • Contract negotiations
  • Predict!’s integrated risk analysis capabilities allows for ‘what if’ scenario analysis to show the sponsor the cost and schedule impact of modifying or removing specific risks.
  • Using an end to end risk management system will give the sponsor confidence that project delivery will be on time and to cost.  It also gives the supplier confidence he can deliver against contracted expectations.

Project delivery

    •  Predict! enables all of the risks and mitigation actions identified when bidding to be seamlessly passed across to the delivery team. No longer will misunderstood spreadsheets get passed across (or not).
    •  The multi access Predict! database allows everyone to see and maintain the risks and actions that are important to them, at anytime. Risk management becomes a day to day activity, not a panic driven activity with everyone trying to update a single spreadsheet in time for a monthly report.
    •  The integrated Monte Carlo schedule analysis engine automatically builds models that enable you to keep track of cost and schedule confidences as the project progresses. ‘What if’ analysis allows the impact of mitigating risks, or changing activity durations to be rapidly visualised, so that the most import actions are performed to ensure on-time delivery.
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