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How Clinical Trial Technology Can Help Contract Research Organizations

People around charts who work for CRO

Contract research organizations (CROs) play a vital role in clinical trials. The CRO market was worth $61 billion in 2020 and is expected to reach $99 billion in 2026. In the midst of the pandemic, CROs helped sponsors test COVID vaccines and also kept essential trials running in cardiology, oncology, and rare diseases. 

But CROs and sponsors still experience gaps in collaboration. In one study, 60% of sponsors said they were generally satisfied with their CRO, but 36% were neutral or generally unsatisfied. 

Many CROs also want to help their sponsors more. 31% of CROs said sponsors seldom or never ask for their input on protocols, even though 91% of CROs would like to assist with the process. 

Clinical trial software can help sponsors and CROs collaborate by allowing them to share protocols, documents, and data instantly. This immediate communication will make working together on protocols and study functions easier, which will lead to more efficient trials.  

Here’s how technology can help contract research organizations thrive. 

1. Establish clear goals

If CROs want to continue receiving studies from sponsors, they need to prove that they can deliver quality sponsors wouldn’t receive when going directly to sites. But WCG Avoca discovered that contract research organizations and sponsors often have different definitions of what constitutes a quality study

This disconnect may explain why more than one-third of sponsors aren’t satisfied with the quality of their CRO’s work, while 90% of CROs believe they’re delivering high-quality trials. 

Although both sponsors and CROs must accept a Clinical Trial Agreement for each study, these CTAs don’t always contain key performance indicators (KPIs) that both the contract research organization and the sponsor feel comfortable with. 

Ultimately, the sponsor is responsible for the contract’s structure, negotiation guidelines, and requirements–but that doesn’t mean CROs can’t contribute. 

Collaborate on goals with the help of technology

The first step to aligning a sponsor’s goals with a CRO’s goals is constant communication. Replacing some in-person meetings with video calls or secure online messaging can make it easier for sponsors and CROs to communicate briefly and often instead of through lengthy, infrequent meetings. Offering technology and the ability to communicate instantly will help CROs remain competitive, as IQVIA has proved with their innovative trial models

While communicating, sponsors and CROs can establish key performance indicators that they both agree on. These may include activation times, recruitment numbers, rate of completion for case report forms, and data integrity. 

But it’s not enough to just set KPIs. It’s important to make sure the KPIs accurately and fairly measure the CRO’s performance. 

Joelle Herman of CRO NeoTrials provides an excellent example. If a sponsor measures how long it takes a CRO to go from contacting a site to fully activating a site, the CRO may be held accountable for how long it took the site’s Institutional Review Board to approve the protocol. But the CRO has no control over the site’s IRB. 

However, if the sponsor makes the KPI how long it takes for a CRO to activate a site after that site has received IRB approval, CROs will have control over whether they meet the goal. When contract research organizations and sponsors collaborate on goals, they can make sure the goals are relevant to both of them. 

Use technology to gather data for initial decisions

When setting goals, it’s important to use data to make them realistic. For example, a contract research organization could use clinical trial feasibility software to calculate which sites are likely to find enough patients for a particular study. Technology like eISFs and eTMFs can also provide dashboards that show how sites are progressing with recruitment, documents, and tasks. 

If a sponsor then asks a CRO why they chose a particular site or a particular timeline, the CRO will have data to back up their decision. This data could also justify why some sites take longer to recruit patients than others or why some sites ultimately weren’t the right choice for the study. 

2. Share documents and data quickly

When sponsors and CROs send documents back and forth via email or sponsor portals, sponsors may feel like communication is too slow and they don’t have a clear window into the CRO’s processes. That’s frustrating for sponsors, but it’s also frustrating for CROs. 

In the midst of managing trials, CRO staff don’t always have time to download and scan documents, make sure they have the correct version of a document, and then email a sponsor’s staff individually. But if CROs don’t share documents with their sponsors in a timely fashion, sponsors can lose confidence in the CRO and think they are not transparent. 

Let sponsors view documents and data through secure software 

A lack of good communication leads to collaboration failures. Some sponsors and CROs get around this problem by sharing a secure software system, like an eTMF

The CRO can choose an eTMF and give their sponsor permission to view documents and folders within it, or the sponsor can choose an eTMF and distribute it to the CROs they work with. Either way, the CRO can store information in a secure space and then give the sponsor permission to view relevant documents. 

When the CRO uploads new data or an updated version of a document into the eTMF, the sponsor can log in and see it instantly. The CRO won’t have to remember to email documents to the sponsor or upload copies to a separate portal.

Contract research organizations have a duty to provide documents to their sponsor, but the more quickly and effortlessly they can provide those documents, the better communication between CROs and sponsors will be. 

Work together on protocol documents

CROs have a strong desire to help sponsors with protocol design. 91% of CROs think collaboration would improve protocols. 

But 53% of CROs said sponsors occasionally collaborated on protocols, 19% said they seldom did, and 12% said they never did. Sometimes this is just because sponsors want to have complete control over the protocols–but sometimes, it’s because collaboration is time-consuming and frustrating.

Compliant technology can make working together easier. Sponsors and CROs can share protocol documents instantly through a secure platform, then leave comments for one another to request revisions or additions. This will let sponsors create protocols that CROs are happy with and will let CROs share their expertise with sponsors. 

3. Reduce turnover and make work easier for CRO staff

CROs have a high turnover rate, typically between 24% and 29%. CRO staff leaving and being replaced so frequently creates a challenge for both the CRO and their sponsor. 

Sponsors worry about CRO staff leaving in the middle of a study and the study slowing down as a result, and CROs might owe their sponsor compensation if delays occur because of turnover. 

Hiring and training new employees is also time-consuming. CROs must notify sponsors when the trial team has changed and provide information on the new team members if the sponsor requests it. This process takes even more time. 

So how can CROs and sponsors reduce turnover? 

Use technology to take the burden off CRO staff

The heavy workloads and long hours at CROs contribute to high turnover. If you’d like to learn more about how to reduce burnout and therefore turnover, you can check out our article on combating burnout in clinical research. One solution for turnover and burnout is to hire more staff–but that isn’t always possible. 

Technology can cut down on timely manual processes like printing, copying, scanning, and filing that don’t require an employee’s expertise but still take up large amounts of their time. However, it’s important to choose technology that’s easy for staff to learn and use

It’s also important to thoroughly document the training process. Look for technology vendors who are willing to provide initial training and then help you create SOPs for new employees. 

Help CRO staff use their skills with less stress 

The most sought-after skills for CRO staff include communication, project management, and data analysis. Though software can’t replace any of these human skills, it can assist with them. 

Having a single eTMF where all documents and data are uploaded can improve communication within CROs and between CROs and sponsors. Employees can also benefit from seeing which tasks still need to be completed or which documents need signatures. 

Finally, Nature notes that large CROs like Paraxel are hiring more data scientists who can extract insights from EHRs and digital devices. Software that can store source data, let scientists quickly search it, and even help with data sorting and analysis will help CROs achieve their data analysis goals, even if they can’t afford to hire dozens of new employees. 

Software Can Help CROs Address Their Unique Challenges

Contract research organizations perform many of the same duties as sponsors. But they also have unique challenges like communicating with sponsors and sites, sharing documents and data on strict timelines, and reducing turnover while still offering data analysis and project management services. 

Technology can’t solve all of these problems–having smart, efficient CRO employees and well-documented processes will always matter–but it can help with all of them. If your team would like more information about how Florence’s technology can help with a CRO’s challenges, check out our complete guide to the modern eTMF

Sources

Herman, J. (2018, September 27). 5 major challenges in CRO outsourcing – and how to overcome them

. Clinical Leader. Retrieved October 7, 2021, from https://www.clinicalleader.com/doc/major-challenges-in-cro-outsourcing-and-how-to-overcome-them-0001.

Landhuis, E. (2018). Outsourcing is in. Nature, 556

(7700), 263–265. https://doi.org/10.1038/d41586-018-04163-8

Schramm, D., & von der Weid, K. (2020, December). Managing contract research organizations and common risks in outsourced clinical trials

. Insights | Sidley Austin LLP. Retrieved October 7, 2021, from https://www.sidley.com/en/insights/publications/2020/12/managing-contract-research-organizations-and-common-risks-in-outsourced-clinical-trials.

Whittaker, S. B. (2015, July 14). Quality of outsourced trials: Why do disconnects still exist between sponsors and CROs

. Clinical Leader. Retrieved October 7, 2021, from https://www.clinicalleader.com/doc/quality-of-outsourced-trials-why-do-disconnects-still-exist-between-sponsors-and-cros-0001.

Wood, L. (2021, June 15). Global Contract Research Organization Market Report 2021

. GlobeNewswire News Room. Retrieved October 7, 2021, from https://www.globenewswire.com/en/news-release/2021/06/15/2247070/28124/en/Global-Contract-Research-Organization-Market-Report-2021.html

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