Join Navitas Life Sciences at SCDM 2023

Navitas Life Sciences will showcase as a strategic partner at the upcoming SCDM Live Annual Conference – The Festival of Clinical Data Science, between 08 - 11 October 2023 in the Hilton San Diego Bayfront, San Diego, CA, USA. Our team of experts will be present to discuss insights that will transform your Clinical Data landscape.

In this blog we met with the experts to understand their perspectives on the evolving field and to find out more about the insights they will be sharing at SCDM.

Date: Wednesday, October 11 | 10:30 – 11:45 PST

Session Title: Pursuing fit-for-purpose data – Best practices for implementing an outcome-based RB-CDM strategy

Presented by: Dr. Yun Lu, VP and Chief Science and Innovation Officer, Navitas Clinical Research

Dr. Yun Lu, PhD

Vice President & Chief Science and Innovation Officer

Please give us a brief overview of what an outcome-based RB-CDM strategy entails, and why it's crucial for modern clinical trials.

Risk-based clinical data management (RB-CDM) or quality management includes the following critical components:

• RB-CDM is a proactive and pre-defined quality by design (QbD) approach and risk based clinical data management plan. The ultimate goal is to support study data integrity and reliability of conclusions.
• RB-CDM is a cross functional effort. It requires combined experience, expertise and group decisions to identify critical to quality factors (CtQ), actions to prevent risks negatively impact study outcomes and participant safety.
• RB-CDM is an end-to-end implementation process and actions based on the risk-based data management plan. RB-CDM needs to be carried out through the entire study life cycle, it continuously improves and evolve RB—CDM plan
• Last but not least, RB-CDM has two levels to consider: organizational level policy, strategy and SOPs; and individual study level plan and implementation.

What are some of the key challenges organizations face when implementing an outcome-based RB-CDM strategy, and how does Navitas address them?

Navitas Life Sciences, at the organizational level forms a multi-disciplinary core group to lead and drive RB-CDM initiatives and develops end-to-end planning and implementation policy and process. At the study level, the Navitas Team does not wait until everything is perfect. We start with a pilot effort, which can be client requested and/or an internal effort. Based on our experience, we found that implementing fewer end-to-end CtQ is better than trying to come up with a complete list of factors.

Technology and eSolution are very important to support RB-CDM implementation. RB-CDM requires clinical data managers with a more complex background and skillset. The clinical data manager needs to have the ability to think critically and to leverage available technologies and processes across functions.

We, at Navitas Life Sciences, invest effort in identifying missing skills, evaluate if we have internal resources or need to look for external hiring or partnering with other organizations. This may have a greater impact on the organization’s operational model, talent recruitment, internal training program, study timeline and budget.

Date: Tuesday, October 10 | 14:15 – 15:15 PST

Session Title: What about the role system providers must play together to enhance clinical trials patient’s journey.

Presented by: Omar Khalid, Clinical Data Manager II, Navitas Clinical Research

Omar Khalid

Clinical Data Manager II

Give us a sneak peek into the session on ‘What about the role system providers must play together to enhance clinical trials patient’s journey.’

Technology is becoming increasingly woven into our daily lives, and the world of clinical trials is no exception: penetration of technology in the clinical trials settings has been spectacular. As the industry has significantly increased its volume of data sources, vendors, and systems, it is essential to move forward to better co-ordinate and connect technology systems and services. Despite the shift towards decentralized clinical trials (DCTs), patients and sites are still the key players of clinical trials, and they remain the ones in need of using multiple technologies. But sick patients and very busy site staff are not necessarily experienced with the multiple systems they must use and express a clear need for simplification.

How can system providers better work together to streamline clinical trials operations? How can we make sure that systems become sufficiently interoperable to facilitate the sites and patients’ journey?

Through insightful case studies and illustrative examples, this session will review recommendations for systems integration, and will show the value that simple, interoperable platforms can have on patients and sites experience. It will also demonstrate that by facilitating access, reducing redundancies, and optimizing data review, successful systems integration positively impacts clinical trials data quality.

What will you focus on during the session?

My portion of the session focuses on how Clinical Data Managers (CDMs) play a pivotal role throughout clinical research, especially with the rising use of direct-data technology. Their expertise in system implementation and hands-on design experience positions them as key advisors for optimizing data collection and clinical operations while maintaining data integrity. I'll share my insights on what CDMs need to know to excel in these responsibilities within clinical trials.

Can you please give us examples?

One of my projects is a medical device trial that collects data using Standard Assessments (copywritten medical instruments). One of the forms was incredibly long but needed to be viewed by a patient on any screen, including smartphones, tablets, or computers. We first learned from the instrument owner what his conditions were to make an ePRO and knew we could not change any of the text. Our solution was to change the visuals so that each question in the form would appear one at a time. This maintained the data integrity while decreasing the patient burden when viewing the forms.

Another example involves automating the workflow rather than form design itself. Some CRFs and Assessments may or may not be answered based on the responses of the forms before it. This is especially true during screenings. Our team did a thorough review of the ePRO workflow to see where we could automatically populate certain data from one form to another, or even automate removal of the forms altogether. Automating the workflow in this manner greatly reduces both patient and site workflows without compromising any form design.

Reena Jenifer Ratna D

Senior Project Data Manager

What are some emerging technologies or approaches that you believe hold great promise in improving the patient experience throughout the clinical trial process?

In the growing landscape of Clinical Research, a promising approach I believe is the evolution towards Decentralizing the clinical trials (DCT). It not only enhances a patient’s experience with user friendly technologies but also reduces the burden on them.

There will be greater importance on technologies like eCOAs and ePROs playing a vital role in improving a patient’s journey throughout the study. Such advanced technologies have the capacity to streamline data flow and automatically validate it, ensuring the highest quality of data. Patient safety is under constant vigilance, providing optimal support without the need for direct intervention.

How do you see the landscape of clinical data management evolving in the next few years, and what should professionals in the field be preparing for?

Clinical Data Management’s shift towards Clinical Data Science is evident in recent years. It is going to be deeply entrenched into every aspect of clinical data management, evolving around the science of extracting significant insights from the study data.

It is important that professionals in this evolving landscape are equipped with skillsets like data analysis and visualizations, statistics, artificial intelligence, image processing and machine learning.

Collaborative role system providers play in enhancing the patient's journey in clinical trials - examples of successful collaborations you've witnessed or been a part of?

In a study where an efficient system was crucial for gathering patient-reported outcomes over an extended study period, encompassing various data types, we developed a resilient system that not only met the study's demands but also elevated the overall patient experience. This included user-friendly interfaces, uncomplicated modules with adaptable designs, multilingual displays, and validation prompts featuring helpful tips and instructions for patients. Additionally, an alert system utilizing emails and messages ensured constant monitoring for safety. This transformed what could have been a challenging endeavor into an engaging and ultimately successful collaboration.

Kimberly Flotta

Director of Business Development

What is Navitas Life Sciences about and why should attendees at SCDM 2023 meet with our experts?

We are a full-service CRO supporting diverse clients like you with the design, execution and result analysis of their observational studies, registries, and clinical trials. We have helped s bring innovative drug treatments, medical devices and other interventions to the market since 1986. Our nearly three decades of experience enables us to predict needs, avoid common barriers, and move from a quick start-up through each research phase to the successful execution of your project.

How can Navitas Life Sciences help pharmaceutical companies navigate the complex challenges in the industry at SCDM 2023?

At SCDM 2023, we bring vast experience and deep expertise to the table. This allows us to not only anticipate industry needs but also preempt common hurdles. We facilitate a swift start-up and guide companies seamlessly through each phase of the clinical trials.

What innovative strategies can attendees uncover at SCDM 2023 with Navitas Life Sciences?

We'll be exploring multiple groundbreaking strategies at SCDM 2023 like Risk Based monitoring, decentralized clinical trials and the use of technology to enhance clinical data management. Such innovative approaches are set to revolutionize the way clinical trials are conducted.

What unique advantages can attendees gain from meeting Navitas Life Sciences experts at SCDM 2023?

Meeting our experts in person provides a valuable opportunity for our team to directly engage with you. We're eager to understand your specific challenges and explore potential solutions. Additionally, you'll have the chance to experience our solutions firsthand through meaningful discussions by scheduling a meeting with our experts.

Our technology-driven solutions seamlessly integrate data management, clinical operations, safety monitoring, and regulatory compliance, providing comprehensive solutions that enhance efficiency and accelerate clinical trial timelines. We're excited to connect with you at SCDM 2023!

SCDM Live Annual Conference

Date: 08 - 11 October 2023

Venue: Hilton San Diego Bayfront, San Diego, CA, USA

Dr. Yun Lu, PhD

Vice President & Chief Science and Innovation Officer

Omar Khalid

Clinical Data Manager II

Kimberly Flotta

Director of Business Development

If you would like to arrange to meet with our team onsite, please click here.

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