3 STRATEGIES TO CAPTURE NEARLY 100% ACCEPTABLE RESPIRATORY DATAYour guide to improving data quality in your next clinical trial

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23 STRATEGIES TO CAPTURE NEARLY 100% ACCEPTABLE RESPIRATORY DATA

3. CENTRALIZE DATA REPORTING AND ANALYSIS2. OPTIMIZE DATA COLLECTION1. DRIVE QUALITY AT THE SITE LEVEL

1. DRIVE QUALITY AT THE SITE LEVELA. Select optimal sites using historical performance data 4B. Achieve research-grade data with indication-focused education 5C. Avoid common (and uncommon) mistakes by leveraging project management 6D. Simplify global study logistics 7E. Offer dedicated site support 8

2. OPTIMIZE DATA COLLECTIONA. Integrate site equipment with intuitive, protocol-reinforcing software 9B. Demand quality in data management 10

3. CENTRALIZE DATA REPORTING & ANALYSIS A. Optimize central overread 11B. Access holistic, real-time data in one portal 12C. Invest in enhanced business intelligence reporting (beyond overread) 13

33 STRATEGIES TO CAPTURE NEARLY 100% ACCEPTABLE RESPIRATORY DATA

3. CENTRALIZE DATA REPORTING AND ANALYSIS2. OPTIMIZE DATA COLLECTION1. DRIVE QUALITY AT THE SITE LEVEL

Get your compound to market faster with precise, high-quality respiratory data

Clinical trials that collect respiratory endpoints are among the most expensive to conduct and recruiting patients is increasingly difficult and costly. Therefore, it is vital that data from all patients actively contribute to the overall success of the study and development program.

Respiratory data quality is historically judged by acceptability to ATS/ERS (American Thoracic Society/European Respiratory Society) minimum standards. Without centralized data, studies may struggle to attain levels of 80% acceptability.

In this guide, we identify three strategies to help you capture nearly 100% ATS/ERS acceptable respiratory data in your next clinical trial:

THREE STRATEGIES FOR HIGHER DATA QUALITY IN YOUR NEXT TRIAL1. DRIVE QUALITY AT THE SITE LEVEL

2. OPTIMIZE DATA COLLECTION

3. CENTRALIZE DATA REPORTING AND ANALYSIS

43 STRATEGIES TO CAPTURE NEARLY 100% ACCEPTABLE RESPIRATORY DATA

DRIVE QUALITY AT THE SITE LEVEL

A. Select optimal sites using historical performance data

Analyzing past performance data allows you to predict how sites are likely to perform in the future — enabling you to select the best sites for future studies.

With this tactic, you'll benefit from:

> Fewer initiated sites

> Shorter recruitment durations

> Reduced errors in pulmonary function tests

> Decreased data variability

53 STRATEGIES TO CAPTURE NEARLY 100% ACCEPTABLE RESPIRATORY DATA

3. CENTRALIZE DATA REPORTING AND ANALYSIS2. OPTIMIZE DATA COLLECTION1. DRIVE QUALITY AT THE SITE LEVEL

TRAINING

Establish an effective investigative site training program to reinforce research-grade principles, tailored for your target indication. We also recommend using the training program to retrain low-performing sites as the trial proceeds.

With this tactic, you'll benefit from:

> More consistent results

> Optimal data quality for each patient visit

> A better patient experience

> Fewer delays to last-subject-last-visit

B. Achieve research-grade data with indication-focused education

63 STRATEGIES TO CAPTURE NEARLY 100% ACCEPTABLE RESPIRATORY DATA

Rely on dedicated project managers to ensure proven, accountable processes, encourage adaptive problem solving and provide expert guidance.

With this tactic, you'll benefit from:

> Proactive study set up, execution and close out

> Less time identifying and fixing issues

> Higher data quality

> Shorter time-to-market

3. CENTRALIZE DATA REPORTING AND ANALYSIS2. OPTIMIZE DATA COLLECTION1. DRIVE QUALITY AT THE SITE LEVEL

C. Avoid common (and uncommon) mistakes by leveraging project management

73 STRATEGIES TO CAPTURE NEARLY 100% ACCEPTABLE RESPIRATORY DATA

Leverage a dedicated in-house logistics team that coordinates with existing global hubs. Ship multiple devices in one box and plan for spare replacement devices among hubs.

With this tactic, you'll benefit from:

> Greater control and flexibility

> Faster site support (and happier sites)

> On-time delivery

> Reduced costs

D. Simplify global study logistics

3. CENTRALIZE DATA REPORTING AND ANALYSIS2. OPTIMIZE DATA COLLECTION1. DRIVE QUALITY AT THE SITE LEVEL

83 STRATEGIES TO CAPTURE NEARLY 100% ACCEPTABLE RESPIRATORY DATA

E. Offer dedicated site support

Expand your site support with a dedicated, multi-lingual help desk that's accessible 24/7/365. First-level, local agents are also especially helpful in China and Japan for relevant studies.

With this tactic, you'll benefit from:

> More efficient (and satisfied) sites

> Higher quality data

> Faster response time

3. CENTRALIZE DATA REPORTING AND ANALYSIS2. OPTIMIZE DATA COLLECTION1. DRIVE QUALITY AT THE SITE LEVEL

93 STRATEGIES TO CAPTURE NEARLY 100% ACCEPTABLE RESPIRATORY DATA

A. Integrate site equipment with intuitive, protocol-reinforcing software

Integrated site devices and smart software allow for real-time feedback and study-specific workflows through an intuitive user interface.

With this tactic, you'll benefit from:

> Improved protocol compliance

> Better data quality

> A reduction in incorrect patient inclusions and exclusions

> Less site burden (and potentially more patients enrolled)

OPTIMIZE DATA COLLECTION

SPIROMETRY FeNO OSCILLOMETRY HOME MONITORINGECG

10

3. CENTRALIZE DATA REPORTING AND ANALYSIS2. OPTIMIZE DATA COLLECTION1. DRIVE QUALITY AT THE SITE LEVEL

3 STRATEGIES TO CAPTURE NEARLY 100% ACCEPTABLE RESPIRATORY DATA

Lean on a dedicated data management team with expertise for smarter queries that do not overburden sites. Efficient and experienced data set-up plans and flexible processes should accommodate sponsors of different sizes in order to meet their unique needs.

With this tactic, you'll benefit from:

> Identification of all errors

> More efficient DSMB (Drug Safety Monitoring Board) reviews

> Reduced site burden

> Rapid study completion

> On-time, accepted respiratory file transfers

B. Demand quality in data management

113 STRATEGIES TO CAPTURE NEARLY 100% ACCEPTABLE RESPIRATORY DATA

CENTRALIZE DATA REPORTING & ANALYSIS

A. Optimize central overread

Experienced, trained overreaders help to accurately identify drug responders through centralized data analysis at the study visit level. Central overread, ideally while the patient is still at the clinic, also provides better informed baseline disease determinations and inclusion/exclusion decisions.

With this tactic, you'll benefit from:

> Higher data quality

> Reduced risk

> Reduced inter/intra-reader variability

> Improved study power

> More accurate drug responder analysis

WITHERRORS

3.3 MILLION FEV1 MEASUREMENTS

Repeatability

Number of efforts

Poor start of test

End of test

CoughTechnical

Incorrect deselection

25%

19%

3%

13%

3% 1%

36%

11%

In a recent study conducted by ERT, approximately

3.3 million lung function assessments were analyzed

across a variety of endpoints. Unfortunately,

approximately 11% of the tests submitted by

investigators still had some form of error, despite

initial basic equipment training. When inappropriate

best test data were deselected and a more

appropriate test result was selected, the average

changes in FEV1 values were approximately 112 mL.

12

3. CENTRALIZE DATA REPORTING AND ANALYSIS2. OPTIMIZE DATA COLLECTION1. DRIVE QUALITY AT THE SITE LEVEL

3 STRATEGIES TO CAPTURE NEARLY 100% ACCEPTABLE RESPIRATORY DATA

Centralize data access with a single sign-on portal (across all endpoint data) and real-time user alerts. Achieve holistic study visibility with standard and configurable visual reports, integrated data clarification requests and site receipt confirmation of requests and reports.

With this tactic, you'll benefit from:

> Real-time view of study trajectory

> Optimized data collection throughout the study

> Evaluation of site intervention and retraining impact

> Reduced management time

> Clear focus on study issues

B. Access holistic, real-time data in one portal

13

3. CENTRALIZE DATA REPORTING AND ANALYSIS2. OPTIMIZE DATA COLLECTION1. DRIVE QUALITY AT THE SITE LEVEL

3 STRATEGIES TO CAPTURE NEARLY 100% ACCEPTABLE RESPIRATORY DATA

Invest in business intelligence reporting that helps you proactively identify site data issues and fraud, analyze true subject outliers and leverage grading systems to assess site performance compared to other sites. Armed with these actionable insights on site and patient risks, your team can quickly focus on fewer sites (those that need the most help).

With this tactic, you'll benefit from:

> Rapid identification of root cause and resolution of issues

> Increased study power

> Reduced variability and study costs

> Reduced risk of data loss by catching fraud earlier and preventing sites from entering patients later removed from study data

C. Invest in enhanced business intelligence reporting (beyond overread)

99%

97%

95%

93%

91%

89%

87%

85%1 2 3 4 5 6 7

MONTHS

FIRST STUDYNo enhanced business intelligence

SECOND STUDYWith enhanced business intelligence

AC

CEP

TAB

LE D

ATA

Retraining for sites with poor

data quality

LEVERAGE REPORTING TO IDENTIFY ISSUES IN REAL-TIME AND PROACTIVELY

RETRAIN SITES FOR HIGHER DATA QUALITY

143 STRATEGIES TO CAPTURE NEARLY 100% ACCEPTABLE RESPIRATORY DATA

Actively manage your respiratory data quality and lower trial costs

While at first glance these strategies may appear to be time-consuming and costly, the downstream benefits are potentially significant — a greater percentage of acceptable data can be collected, resulting in fewer patients, increased statistical power and reduced costs.

Don’t risk letting your data quality suffer. Instead, implement active management of data quality to succeed with your compound.

Learn how you can improve respiratory data quality with ERT.

ABOUT ERT

ERT is a global data and technology company that minimizes uncertainty and risk in clinical trials so that customers can move ahead with confidence. With nearly 50 years of clinical and therapeutic experience, ERT balances knowledge of what works with a vision for what’s next, so we can adapt without compromising standards.

Powered by the company’s EXPERT® technology platform, ERT’s solutions enhance trial oversight, enable site optimization, increase patient engagement and measure the efficacy of new clinical treatments while ensuring patient safety. Since 2014, more than half of all FDA drug approvals came from ERT-supported studies. Pharma companies, biotechs and CROs have relied on ERT solutions in 10,000+ studies spanning more than three million patients to date. By identifying trial risks before they become problems, ERT enables customers to bring clinical treatments to patients quickly — and with confidence.

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