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COVID-19: CRO – Financial Health Check

COVID-19: CRO – Financial Health Check

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COVID-19 has a big impact on the current business volume of CROs. And so questions arise how long CROs can suffer this downturn in business volume without getting financially in troubled water.

CLICK HERE to get your free COVID19 Financial Health Check advice

Here are the facts:

  • Worldwide stopped trails this year until May: 1.118
  • This is 16% of all trials started per year.
  • The average operating margin of CROs is between 9-14% of the revenue.

Any sponsor shall be concerned about this the financial impact of COVID-19 on their vendors.

As a measure of risk management, we provide a financial health check of your CRO.

This is to make sure, that the CRO is still financial stable with a good outlook over the next years.

CLICK HERE to get your free COVID19 Financial Health Check advice

COVID-19: Make sure that your CRO is still financially stable

  • Financial Health Check of CROs

  • Free first advice upon request

CLICK HERE to get your free COVID19 Financial Health Check advice

 

 
CRO Change Order received! – Why Worry?

CRO Change Order received! – Why Worry?

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In the current business climate, pharmaceuticals and biotechs are facing increased numbers of uncertainties with regards to financial planning. Not only are investment funds from government agencies (NIH) being reduced, but also the user fees for the FDA are planned to increase. In order to address unforeseen financial problems, pharma and biotechs entering clinical trials need to ensure they are receiving a good return from their investment in clinical trials. Outsourcing to CROs is a crucial point in managing clinical development costs.

Does this sound familiar to you?

  • You do not want to discuss change orders over and over again?

  • Your clinical trial costs increases and you do not know how to stop this financial drain?

  • You want to get rid of unhelpful discussions with your management about budget increases in your projects?

  • You want to focus on operations and not on financials?

If your answer is YES, then be aware: there is a solution for you:

The cheat sheet „6 smart questions that will reduce your change order instantly“.

Our cheat sheet will show you the six simple questions that will reduce your change order instantly. You can do this without special financial knowledge. No expensive consultants needed. No lengthy, tedious CRO negotiations. Just read our cheat sheet and follow the easy instructions.

For many biotechs, change orders are a common experience in clinical trials. And they are an additional source of uncertainty in the clinical trial process as they entail an increase of the development costs. They might be spurred by unforeseen circumstances or emergencies or unfortunately by a lack of diligence in the clinical trial planning and budgeting process. Change orders represent a headache for project managers, as they represent the unenjoyable task of seeking management approval for the increase in budget and spending.

However, in my experience change orders do not necessarily need to bring about an increase in cost. When change orders occur, we take the time to reassess and reanalyze the financial planning of the trial budgets in total. We understand change orders as a chance to bring a list of other sections in a budget where there is room for cost reductions. Usually some budget items increase as assumptions changed, but they might be balanced out by other changes in the project where cost efficiencies allow cost reductions to be realized.

Can you imagine going to your management and announcing that there has been a 7-digit change order request from the CRO, but then being able to tell them that after several negotiation rounds the project costs did not increase? That is what we achieved to this extent only once but zero amount change orders or even overall cost reductions are not uncommon in our experience. The importance is to negotiate about efficiencies where quality and patient safety is not affected.

In order to do this, CILIQUE provides quite unique service for small and mid-sized biotechs. With our 12 years of experience in clinical trial budgeting and CRO contracts, sponsors can reduce overall clinical project costs while ensuring that the CRO spends the funds allotted in a responsible and effective manner. This process includes not only the selection of the CRO but also the negotiation of the budget and contract. Lastly, during the project, CILIQUE assists with the ever-troublesome change orders.

Project managers need to demonstrate to their management how funds are being spent in clinical trials and the ability to avoid costs increases where possible. If you are faced with cost increases in your current change order process, contact CILIQUE and request a non-binding estimate on how to alleviate your situation to give your clinical trials more financial reliability. Understand your next change order as a chance to reshuffle the cards and to play your trump card.

And: There is a solution!

The cheat sheet „6 smart questions that will reduce your change order instantly“.

Our cheat sheet will show you the six simple questions that will reduce your change order instantly. You can do this without special financial knowledge. No expensive consultants needed. No lengthy, tedious CRO negotiations. Just read our cheat sheet and follow the easy instructions.

 
CILIQUE is attending Healthtech Invest Europe 2017

CILIQUE is attending Healthtech Invest Europe 2017

Healthtech Invest Europe 2017 will take place on 15-16 March 2017 in Helsinki, bringing together leading investors from Europe and some of the most promising Health Tech entrepreneurs of Europe and Finland. The event will concentrate on the following subsectors:

  • Medical Devices & Diagnostics
  • Digital Health
  • Connected Health & Sensors
  • Wearables and Well-Being Technology

40 of the best European early stage Healthtech companies will be selected to present at the event by the investors of the selection committee. The applying companies will be assessed on the basis of their business potential, product and technology merit, competitive position, investment or partnering interest, team experience and project quality. Healthtech Invest Europe (HIE) will allow entrepreneurs to meet and present themselves to active international investors and corporations seeking investment and partnerships.

Meet our colleague at: Healthtech Invest Europe 2017 

 
Clinical Development Likelyhood of Approval tripple when using Biomarkers

Clinical Development Likelyhood of Approval tripple when using Biomarkers

Clinical trial programs that used selection biomarkers saw an overall likelihood of approval (LOA) from Phase I of 25.9%, compared to 8.4% when no selection biomarkers were used. This one of the results of  the largest ever study of clinical development success rates released by the Biotechnology Innovation Organization (BIO). The study, conducted in partnership with Amplion and Biomedtracker, recorded and analyzed 9,985 clinical and regulatory phase transitions, across 1,103 companies. Using clinical trial data from the past decade, “Clinical Development Success Rates 2006-2015” compares groups of diseases, drug modalities and other attributes to generate the most comprehensive analysis, to date, of biopharmaceutical R&D success.

You can download the full report here: Clinical Development Success Rates 2006-2015

 
How effective is your CRO and Vendor Oversight ?

How effective is your CRO and Vendor Oversight ?

Oversight is YOUR responsibility no matter what you outsource and to which vendors you work with. You are accountable fully in the eyes of healthcare regulators and Patients alike. You can join this webinar from MACROCARE to explore some best practices and benchmark how you are doing currently on risk management and compliance areas that feed into your overall Oversight. This webinar is designed to cover following aspects:

  • Criticality of Oversight in clinical projects
  • Developing an effective Oversight plan
  • Selecting right areas to oversee, metrics and risk management planning
  • Add compliance, RBM and Central Monitoring also to the same plan as an option
  • See how technology is key enabler to Oversight

Click here to register …

 
60% cheaper clinical trials in Australia compared to US

60% cheaper clinical trials in Australia compared to US

 

Conducting clinical trials in Australia could save up to 60% of the average clinical trial costs compared to the US. That is the outcome of a report published by Frost & Sulivan, which can be accessed on the website of Novotech. Novotech is partnering with Deloitte to brief early stage companies to take advantage of this cost gap. According to the white paper this price advantage is possible because the Australian „… government offers attractive R&D tax incentives including cash rebates. According to a cost comparison study, Australia is 28% cheaper than the US before tax incentives; and 60% cheaper after tax incentives. …“.

unbenannt

Source: Cost comparison for Phase 1 clinical trial in the US and Australia. Novotech cost comparison case study. 2016. in Frost & Sullivan White Paper „Australia: Preferred Destination for Early Phase Clinical Trials“, Page 11

In summary the report further names three additional key benefits that make conducting clinical trials in Australia attractive:

  • Cost-efficiency as described above,
  • Regulatory Speed and Flexibility,
  • Quality as Australia’s scientists rank highest in Asia Pacific.

Further details about the benefits of conducting clinical trials in Australia can be also found in „Australia’s Clinical Trials Capability Report“ to be found on the website of the Australian Trade and Investment Commission, which further names the following benefits of Australia:

  • Quality medical research infrastructure and a skilled workforce
  • A world-class healthcare system
  • Attractive Research & Development (R&D) Tax Incentives for clinical trials
  • A fast, pragmatic regulatory pathway
  • Clinical data which complies with the highest international standards
  • A strong intellectual property system
  • A national focus on continuous improvement through government reform and policy innovation
  • An ethnically-diverse, English-speaking population
  • Proximity to Asia
 
The Changing Role of the CRO and its Effect on Project Management

The Changing Role of the CRO and its Effect on Project Management

The increased complexity of clinical trials places greater strategic demands on CROs and project managers (PMs). To ensure operational excellence and financial profitability under an ever-changing and challenging clinical trial environment, the role and profile of the PM needs to continuously evolve beyond the management of the “triple constraint.”. The competencies of the PM in the past are not those required for today.

In the past, PMs adhered to a simplistic but still established service triangle of time, cost and quality (i.e., triple constraint). But today that model has evolved significantly and PMs really need to sit in the driver’s seat, be fully accountable, push innovation, provide strategic leadership and drive more thorough risk analysis and management, ultimately ensuring return of R&D investments and delivery of perceived customer value.

Volker Hack and  Denise Sackner (PPD) precisely outline in  their recent article in appliedclinicaltrialsonline.com „The Changing Role of the CRO and its Effect on Project Management“ what the new competencies are that successful project managers need to fulfill all the new challenges in modern clinical trials. (Read more…)

 

 

 
David or Goliath? – Is a Bigger CRO Better?

David or Goliath? – Is a Bigger CRO Better?

The importance of midsized CROs in pharmaceutical and medical device development.

It’s no surprise to industry insiders that the largest pharmaceutical companies rely on the largest contract research organizations (CROs) for the lion’s share of their outsourced R&D. For example, in the first quarter of 2015, 34% of ICON’s total revenue (approximately $134 million of its estimated more than $500 million in annual sales) was with one client, presumably Pfizer; […] ICON, Parexel and PPD all have partnerships with Pfizer; Covance (LabCorp) has partnered with Eli Lilly, Bayer and Sanofi; and Quintiles has partnered with Takeda and Roche, to name a few.

The leading model for these relationships has increasingly become based on strategic partnerships offered by CROs. Strategic partnerships have largely supplanted project-by-project and preferred provider outsourcing methods, and for good reason. To remain profitable, sponsors are seeking greater productivity from their R&D investments, and this is often facilitated by highly integrated relationships spanning many years and multiple projects.

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But, what does all this mean for pre-revenue, small and midsized pharma/biotech and medical device sponsors?

In his interesting article, Jason Monteleone explains with well structured arguments, why mid sized CROs might also be a source of world-class technology, global footprint, deep expertise in specific therapeutic areas or technologies or the most talented scientists. 

 
Free online Training: Refocusing on Risk Mitigation in Starting Clinical Trials

Free online Training: Refocusing on Risk Mitigation in Starting Clinical Trials

The webinar will focus on study startup and discuss best practices for the identification and mitigation of potential risks before they occur.

To join and listen to this training just submit your name and email address to us and you can join the training now and at any time in the future.

 Start the video for this online training.

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 Please share if you like this online training.

Foto: Juhan Sonin – ational EHR Design Guidelines – CC BY 2.0

 
WEBINAR: Implementing Earned Value Analysis (EVA) in clinical trials

WEBINAR: Implementing Earned Value Analysis (EVA) in clinical trials

CILIQUE provides an online training about Earned Value Analysis in Clinical Trials. Earned value management (EVM), or Earned value project/performance management (EVPM) is a project management technique for measuring project performance and progress in an objective manner.

It has the ability to combine measurements of the project management triangle:

  • Scope
  • Time
  • Costs

In a single integrated system, Earned Value Management is able to provide accurate forecasts of project performance problems, which is an important contribution for project management. 

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Early EVM research showed that the areas of planning and control are significantly impacted by its use; and similarly, using the methodology improves both scope definition as well as the analysis of overall project performance. More recent research studies have shown that the principles of EVM are positive predictors of project success.

What you will learn in this webinar:

  • Understand the disadvantages of measuring project progress by milestones or money spent
  • Master to predict completion date and final project costs
  • Control your project quality with simple and easy parameters
  • Understand the Earned Value principle and how to implement Earned Valua Analysis in your clinical Trials
  • Maximize your project performance by linking quality with costs and timelines
  • Identify low performing and high performing projects right at the project start

Learn more and register here: http://cilique.de/en/implementing-earned-value-analysis-eva-in-clinical-trials

 

 

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