Brion Regan

	Clinical trial sponsors and CROs are recognizing real benefits from advanced clinical trial technologies. But if they’re still compiling excel spreadsheets to manage performance, they’re not only eating up valuable resources, they’re leaving cost savings, greater visibility and improved collaboration on the table, too.
	
	This 3-part series explores how sponsors and CROs – together and separately – can leverage today’s clinical trial management solutions to create efficiencies, enable greater transparency and keep trials moving ahead.
	
	Read the full series: Part 1, “

Can Technology Foster Better Collaboration?

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	The clinical trial landscape is changing, with contract research organizations (CROs) assuming more control over clinical trials on behalf of drug company sponsors. With so many firms vying for business in the space, having the right set of tools to manage today’s complex clinical trials has never been more important. The right clinical trial management solutions allow CROs to bring sponsors up to speed briskly and with greater transparency.
	
	Imagine you’ve hired a contractor to renovate your kitchen and a curtain is hung on the threshold, completely hindering your ability to see the project. You’re told that the curtain will be opened once a month so you may note progress. For the rest of each month, you’re left wondering whether any work is being done, if the project has hit snags, and if you approve of the project’s direction. I can think of few individuals who would stand for this type of arrangement and yet, until quite recently, that’s the way many CRO-sponsor relationships have functioned. Often, CROs relied on study team resources to manually produce status reports from disconnected spreadsheets and systems, which inherently limits in-stream visibility. But with emerging technology solutions, CROs are now lifting the proverbial curtain to get near real-time insight to trial progress and reveling in new-found business advantages.
	
	The transformation is almost entirely owed to technology-enabled visibility. Transparent CRO performance not only improves the communication between sponsors and CROs, but has a trickledown effect on trial outcomes as well. In the quest to meet clinical trial milestones, successful CROs are saving both time and money by putting technology to work for them and offsetting the burden of digging through an ever-growing volume of study data to produce status reports and metrics.
	
	With transparent information flows, insights are shared on sponsor-accessible platforms in near real-time. This automated approach ensures data is free of human error â a big concern for CROs â and produces an end product that CROs can share with confidence. No longer do CROs need to worry about error-prone reports; instead they can focus on proactively executing the trial against expected timelines and milestones.
	
	An automated, cloud-based approach is also a major selling point for future business. The right clinical trial management solution positions a CRO well ahead of its competitors by offering the kind of transparency sponsors are looking for, and which will soon be an industry best practice thanks to the recent ICH E6 (r2) guidelines amendment.
	
	The next generation clinical trial management system must enable CROs and sponsors to truly collaborate so they can effectively mitigate risks and increase efficiencies. The future demands a connected, centralized solution that minimizes complexity and enables study teams to manage clinical trials with confidence. CROs who take advantage of this sooner vs. later will have a significant leg up on their competitors – and will lead the way in transforming the manner in which trials are managed.
	
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Articles

The last piece in our three-part series on improving efficiencies and sponsor/CRO collaboration through advanced CTMS, reveals a way in which CROs can best their competition in the marketplace.

One Way CROs Can Outshine Their Competition

	Clinical trial sponsors and CROs are recognizing real benefits from advanced clinical trial technologies. But if they’re still compiling excel spreadsheets to manage performance, they’re not only eating up valuable resources, they’re leaving cost savings, greater visibility and improved collaboration on the table, too.
	
	This 3-part series explores how sponsors and CROs – together and separately – can leverage today’s clinical trial management solutions to create efficiencies, enable greater transparency and keep trials moving ahead.
	
	Read Part 1 of the series, “


	
	Clinical trials are reliant on the input and oversight of numerous parties, all working toward one common objective. But the processes, protocols, and tools driving studies can at times appear to be working against one another rather than as a unit. Surely better collaboration can be achieved, but how?
	
	If you opened a grandfather clock to peer at its inner workings, you’d see that producing the time relies on precision and balance. Simple weighted pendulum technology keeps the clock’s mechanisms moving continuously in order to pinpoint the most accurate time.
	
	Similarly, the right balance of process and technology keeps the many components of a clinical trial swinging forward in unison. Every gear of a clinical trial must work flawlessly together in order to focus on its most important deliverable: data.
	
	Imagine a trial monitor producing a near real-time snapshot of at-risk investigator sites in an instant. Or a CRO producing a sponsor-ready report on study or program performance metrics at the snap of a finger. These capabilities and more are available today. The right technology solution shaves time off employee tasks and fosters a more synergistic and integrated work experience â all of which elevate the quality of trial data and the efficiency of trial execution.
	
	From establishing high-quality and timely analytics that inform decisions to automating cumbersome and error-prone manual tasks, the best technology solutions are intuitive and help a clinical trial run more smoothly. Today’s clinical trial management solutions should create efficiencies and transparency, rather than create administrative burden as is the case with their archaic CTMS predecessors. Automating the way trial performance is shared with sponsors could save 40 hours a month alone for CROs. Which amounts to real savings across all trials over a period of years.
	
	Just as the various parts of a pendulum-powered clock are known for working in harmony to keep the most accurate time, all components of your clinical trials should be similarly aligned to deliver an accurate picture of trial performance that drives day-to-day operations and maintains clinical research momentum. Leveraging the right technology to support best practices â along with onboarding forward-thinking people â can go a long way toward achieving the right balance and establishing a collaborative environment.
	
	

Check back next week for Part 3, “One Way CROs Can Outshine Their Competition.”

The second in our three-part series, Improving efficiencies and sponsor/CRO collaboration through advanced CTMS, explores how technology can foster better collaboration.

	Clinical trial sponsors and CROs are recognizing real benefits from advanced clinical trial technologies. But if they’re still compiling excel spreadsheets to manage performance, they’re not only eating up valuable resources, they’re leaving cost savings, greater visibility and improved collaboration on the table, too.

	This 3-part series explores how sponsors and CROs – together and separately – can leverage today’s clinical trial management solutions to create efficiencies, enable greater transparency and keep trials moving ahead.
	
	

Part 1: The Quickest Way to Save $1 Million


	
	While we’ve all heard that developing a new drug costs more than $2 billion, the average cost of a Phase III clinical trial (across all therapeutic areas) is roughly $21 million over the course of about two years. When you break the expenses down by day ($26,000) or week ($134,000), the true cost of a clinical trial comes into clear view. These daily and weekly increments paint a distinct picture of the underlying opportunities to make adjustments that impact your organization’s fiscal health.
	
	

Technology-powered solutions save time and money


	
	One of the quickest ways to brighten the financial picture of a clinical trial is by uncovering inefficiencies in behind-the-scenes operations. By this I mean manually maintained spreadsheets and reports, repetitive tasks and processes, and the all-too-common “waiting to receive data or information.” With contract research organizations (CROs) taking on more clinical trial activities than ever, many are onboarding technology-powered solutions that enable the switch from spreadsheets to automated processes, and checking off boxes in the gained efficiency column along the way.
	
	

Manual processes are extending trial timelines


	
	Manual management and tracking of trial operations such as site activation, on-site monitoring, and issue management, hinders productivity and cumulatively adds days and weeks to study timelines. Stagnant trial oversight practices have employees handling data across multiple entry points, crunching numbers on spreadsheets, and building reports from scratch. These methods consume valuable employee time and leave data vulnerable to errors. Recent reports show less than 6% of trials start on time and just 10% finish on time, resulting in slipping timelines and late deliverables.
	
	

Shave time off a trial’s timeline with the right processes


	
	Using a technology-enabled solution to automate these processes opens the door to an entirely different clinical trial oversight paradigm. What if a CRO could reduce report building activities by 10 hours each week? What if scheduling several meetings each month to review spreadsheets and confirm data integrity became a thing of the past? Would delivering decision-ready insights to the sponsor on-demand change the daily work burden for your employees? The potential savings in time and money realized outshine the investment needed to put the right technology in place. Let’s take the conservative view: assuming your organization is conducting 20 or more trials per year, shortening the timeline of each trial in your clinical development pipeline by one week could add up to more than $1 million in savings (before offsetting for technology costs). Once the right processes are in place, the savings-both in time and money-are there to be had.
	
	

Improve data integrity and produce better analytics


	
	The move to near real-time delivery of actionable insights removes the shackles of error-prone spreadsheets and frees up employees to focus on activities that support the health and performance of the clinical trial. Employees can rely on trustworthy data that delivers relevant and timely insights, enabling them to make decisions and take action faster than ever before.
	
	

What would your organization do with the money saved?


	
	Let’s face it, automation and people processes aren’t the sexiest topics in business, but a brighter financial picture always attracts a whistle. Over time, incremental changes to internal processes can move the needle on a clinical trial’s bottom line. Imagine the cumulative effects of trimming just one week off each clinical trial your CRO runs in a year. Aside from significant financial and productivity gains, new technology solutions provide fertile ground for new innovations and ways to optimize operations across your organization.
	
	

Check back next week for Part 2 of the series, “Can Technology Foster Better Collaboration?”

The first in this 3-part series, Improving efficiencies and sponsor/CRO collaboration through advanced CTMS, reveals the quickest way that sponsors and CROs can save money and thus keep trials affordable and efficient.

The Quickest Way to Save $1 Million

Five Steps to Ensuring Existing Technology Meets the Next-generation RBM Standard


	
	This month, ICH publishes its long-awaited guidelines on how to conduct clinical monitoring in trial management.
	
	An earlier consultative draft said: 

“The sponsor should develop a systematic, prioritized, risk-based approach to monitoring clinical trials… A combination of on-site and centralized monitoring activities may be appropriate…”


	
	Trial sponsors and CROs can expect plenty of tough questions to be posed about whether their current technology platform can really support the next iteration of RBM. But don’t assume that your old technology platform is ready for the scrapheap and that investments in a completely new system are needed.
	
	Sponsors and CROs can integrate existing and emerging technologies and transform their reactive oversight strategies to a more proactive RBM approach. The result? Compliance with evolving guidelines while reducing trial time and costs 15-20% – a win-win for all concerned.
	
	

New (and Old) Technologies Will Drive the Future


	
	The average clinical trial currently uses as many as seven separate data collection systems. To get a complete picture of risk that also applies a holistic approach to RBM efforts, stakeholders will need to incorporate data from all these sources – as well as critical endpoint data.
	
	But to meet the new demands on RBM created by industry expectations and ICH guidelines, sponsors and CROs will need to enhance existing systems as well as add new technology-driven functionality that includes integration, analytics and Key Risk Indicators (KRIs). This can be accomplished in five easy steps – steps well-worth taking when you consider the benefits.

 The next generation of RBM technologies should have features that automate data sharing across systems so that information need only be entered once. This reduces the risk of human error, increases the data collection speed, and frees monitors to spend more time on value-driven activities.

 An effective RBM solution has an analytics layer to drive risk identification and mitigation so that monitors can make decisions about risk in aggregate and rapidly deploy monitors to those sites that need support. The analytics capabilities in these systems should include customizable algorithms and dashboards to track specific trends and risk indicators â alerts that are automatically generated when sites fall out of compliance based on pre-set requirements â and suggested response actions to address identified risks.

Define key risk indicators and risk score cards for specific trials and sites.

 Every trial faces a unique set of risks that change over the course of the trial. An effective RBM platform allows the sponsor and CRO to define KRIs and create weighted score cards that can be adapted to the cadence of the trial to more efficiently track risk indicators.

Provide specific workflows for sites that fall outside the threshold for compliance.

 A state-of-the-art RBM platform links each risk to a specific workflow based on a pre-defined risk assessment plan, automatically schedules related mitigation activities, and generates follow-up reports when mitigation tasks are completed. This enduces the chance that mitigation tasks fall through the cracks.

Simplify the relationship between sponsors and CROs.

 Relationships between sponsors and CROs have become more complex as a result of emerging global regulations, multiple stakeholders and myriad data sources. By leveraging next generation trial oversight and collaboration systems, sponsors and CROs can improve transparency, accountability and flexibility while achieving their shared and individual data integrity goals.

	Although implementing the next generation of RBM technologies will require a significant change in the way organizations think about monitoring and mitigating risk in the trial environment, sponsors and CROs that take the time now to update their systems and transform their approach to risk management will gain significant efficiencies in time and cost savings while they enhance their ability to manage risk. There’s no reason to wait. Sponsors and CROs who adopt the benefits of centralized risk based monitoring can begin reaping the benefits and gaining a competitive advantage even before the ICH addendum goes into effect this month.

, Product Manager, eClinical Insights, ERT

The ICH is publishing its long-awaited guidelines on how to conduct clinical monitoring in trial management. Sponsors and CROs can integrate existing and emerging technologies while transforming their reactive oversight strategies to an RBM approach using these steps.

Brion Regan

Articles

One Way CROs Can Outshine Their Competition

Can Technology Foster Better Collaboration?

The Quickest Way to Save $1 Million

Technology Implications for the New ICH Addendum