Empowering the Team to be Leaders in the Transformation Journey
Mahesh Bhalgat, Group CEO, Veeda Clinical Research Limited, 0
The field of modern clinical research is experiencing a variety of captivating developments that are transforming the landscape of medical research. The emphasis on putting patients at the center, utilizing platform trials, leveraging advanced biomarkers, promoting diversity and inclusion, and ensuring data interoperability are all contributing to the progression of medical knowledge and the enhancement of patient care. Embracing these trends allows sponsors and contract research organizations (CROs) to improve the efficiency, effectiveness, and patient relevance of their studies, ultimately resulting in improved healthcare outcomes for everyone. Through an exclusive interview with CEO Insights, Mahesh Bhalgat, Group CEO, Veeda Clinical Research Limited sheds light on empowering the team to be leaders in the transformation journey.
How have organizational structures, behaviors, and cultures evolved in clinical research?
The evolution of organizational structures, behaviors, and cultures in clinical research has been significant, driven by advancements in technology, regulatory changes, and a growing emphasis on patient-centric approaches. Here are some key aspects of this evolution:
(a) Traditional Hierarchies to Matrix Structures: Initially, clinical research organizations operated with rigid hierarchical structures, where decision-making was centralized. Modern CROs and pharmaceutical companies have adopted matrix structures, promoting cross-functional collaboration. This allows for more flexibility and better decision-making, integrating various departments like clinical operations, regulatory affairs, project management and data management.
(b) From Compliance to Quality Focus: Historically, focus has been on compliance with regulatory requirements to avoid penalties. There is now a greater emphasis on quality and patient safety. This shift is supported by the adoption of Good Clinical Practice (GCP) guidelines and quality management systems.
(c) Collaborative and Agile Approaches: We have come a long way – approaches have become collaborative allowing for improved communication and coordination. Previously, departments often worked in silos, leading to inefficiencies and communication gaps. The adoption of collaborative tools and agile methodologies has improved communication and coordination among teams, driving better outcomes for clients.
(d) Emphasis on Diversity and Inclusion: Addressing diversity in clinical trials has always been challenging despite the clear benefits related to broader demographic coverage. This is now changing through efforts being brought in to recruit participants from various ethnic, gender, and age groups. In 1993, the National Institutes of Health established the Revitalization Act to ensure that racial minority groups are adequately enrolled in clinical trials with measures taken to enhance the enrollment of Black participants. These measures included consideration of recruitment of minority groups in the site selection stage, provision of additional funds to increase the recruitment rate of Black participants, the 2010 launch of the FDA Office of Minority Health and Health Equity, establishment of FDA Drug Trials Snapshots, and the National Institutes of Health mandate for race/ethnicity subgroup analysis in phase 3 trials.
A trend that is now picking up is to look for new trial destinations with naïve patients and India is gaining popularity as a clinical trial destination. This not only addresses the diversity problem but has the potential to dramatically improve the speed of recruitment. This is likely to be true for many of the therapeutic areas given the vast disease burden seen in India. For this reason, sponsors evaluate the inclusion of Indian sites in their clinical trials. At Veeda, we are engaging in the use of real-world data and AI-based approaches for patient matching approaches, accelerating recruitment.
(e) Digital Transformation: Capturing source data accurately and on time is important for good trial management and can help immensely in decision-making. This has now driven a growing trend of replacing paper-based processes and manual data entry with electronic record keeping. The integration of electronic data capture (EDC) systems, remote monitoring, and artificial intelligence (AI) has revolutionized data management and analysis, making trials more efficient and reliable.
(f) Patient Centricity and Decentralized Clinical Trials (DCTs): A move towards patient centricity and the growing use of technology has made decentralized clinical trials a reality. Facilitated by telemedicine and wearable technologies, DCTs allow participants to take part in trials from their homes, increasing accessibility, and convenience and reducing dropout rates. A study published in Pharmaceutical Medicine highlighted that DCTs not only reduce dropout rates but also increase study effectiveness and speed up the process of bringing new drugs to market. Another study in the Journal of Clinical and Translational Science found that decentralized approaches improve trial efficiency by reducing screen failure rates and making consent and enrollment more convenient.
Patient centricity is becoming more important which is seen in good practices related to patient engagement, informed consent, & patient-reported outcomes. This cultural shift aims to improve patient experience & trial retention rates.
(g) Partnering and Engaging Leadership: Leadership that was more directive, focusing only on adherence to protocols and timelines. Modern leaders in clinical research emphasize inspiration, motivation, and fostering a culture of continuous improvement and innovation. CROs now aim to function as consultants for sponsors and help in protocol design and regulatory strategies applying their experience. At Veeda, we follow a model of engaging all levels of the organization as leaders and therefore empower all staff members to be leaders in the transformation journey.
The evolution of organizational structures, behaviors, and cultures in clinical research reflects a broader trend toward flexibility, quality, patient-centricity, and technological integration. These changes are helping to make clinical research more efficient, inclusive, and aligned with the needs of patients and society. While not all of these have penetrated the Indian ecosystem, they will soon make their way.
Tell us about the impact of patient safety in the design, and execution of clinical trials. What measures should leaders take to ensure safety at all levels?
Patient safety is a critical consideration in the design and execution of clinical trials. There are a number of steps in the process that ensure a deep understanding of patient safety.
1. Design Phase: Before a trial begins, a thorough risk assessment is conducted to identify potential safety issues. This includes evaluating the drug's preclinical data and understanding its pharmacological profile. The trial protocol is designed to minimize risks to participants. This includes defining inclusion and exclusion criteria to ensure that only suitable candidates are enrolled. Institutional Review Boards (IRBs) or Ethics Committees review the trial design to ensure that it meets ethical standards and that the risks to participants are minimized.
2. Execution Phase: Participants are provided with detailed information about the trial, including potential risks and benefits, to make an informed decision about their participation. Continuous monitoring of participants is essential to identify and address any adverse events promptly. This includes regular health check-ups and the use of digital tools for remote monitoring. Independent Data Safety Management Boards (DSMB) oversee the trial's progress and ensure that it is conducted safely. They have the authority to recommend modifications or termination of the trial if safety concerns arise.
3. Patient Engagement: Engaging patients in the trial design process can help identify potential concerns which could lead to non-adherence of regimen and can improve the overall trial experience. This includes considering patient preferences and needs. Keeping participants informed about the trial's progress and
any emerging safety issues is crucial for maintaining trust and ensuring their continued participation. At Veeda, we take a specific interest in ensuring good communication is established with patients. This helps in rapid communication of any adverse events and also minimizes the risk of drop out due to lack of engagement or unwarranted fears.
4. Regulatory Oversight: Trials must comply with regulatory guidelines, such as those from the FDA or EMA, which include specific requirements for ensuring patient safety. Even after the trial concludes, participants are often monitored for long-term safety outcomes to ensure that no delayed adverse effects occur.
These measures collectively ensure that patient safety is prioritized throughout the clinical trial process, ultimately leading to more reliable and ethical research outcomes.
What strategies should the leaders adopt to foster cross-functionality across the organization?
Fostering cross-functionality across an organization can significantly enhance collaboration, innovation, and efficiency. Here are some strategies leaders can adopt to achieve this:
1. Establish common goals, emphasize knowledge sharing, and build trust & transparency:
a) Align departmental goals with the overall organizational vision to promote collaboration. When everyone is working towards the same objectives, it encourages a unified approach.
b) Create open channels of communication and encourage regular knowledge sharing sessions. This can be facilitated through regular meetings, collaborative platforms, and internal newsletters.
c) Foster an environment of trust where team members feel comfortable sharing their ideas and feedback. Transparency in decision-making processes can also help build trust across different functions.
2. Embrace diversity and Invest in Technology: Encourage diverse perspectives and ideas from all team members, which can lead to more innovative solutions and a more inclusive work environment. Utilize collaborative tools and technologies that facilitate communication and project management across different departments.
3. Nurture staff development:
Skill enhancement and career growth are important aspects of leadership. These items lead to employee satisfaction and staff retention. One example of how this is implemented in Veeda is through cross-training. As a part of continuous learning programs, Veeda provides a knowledge-sharing platform wherein experts of different functions/departments share their knowledge and expertise. These sessions help identify talent movement opportunities.
4. Recognize and Reward Collaboration: Acknowledge and reward team members who demonstrate strong collaborative efforts. This can be through formal recognition programs, bonuses, or public acknowledgment in meetings.
5. Create leaders: Provide learning and development opportunities for leaders to manage cross-functional teams effectively. At Veeda, we invest in leadership development programs to train leaders to manage and facilitate cross-functional teams effectively.
6. Celebrate Milestones and Small Wins: Recognize and celebrate team achievements to build a positive team spirit. Celebrating small wins can boost morale and foster a sense of collective accomplishment. Sharing the successful completion of an important milestone such as the first patient should be used as an opportunity to communicate progress and for recognition.
Gen Z will be the largest working-age population, bringing their tech-savvy habits and unique healthcare needs. How do you attract top talent to the industry?
At Veeda, we take the approach that the employee is our biggest asset. Attracting top Gen Z talent to the healthcare industry requires a strategic approach that aligns with their values, tech-savvy nature, and unique needs. For Gen Z, it’s important that work has a purpose and can be impactful. Towards this ask, as a CRO, we are constantly affecting lives by contributing to advancing healthcare and improving patient outcomes. Another important value is that of Diversity, Equity, and Inclusion (DE&I). At Veeda, we look for opportunities to not just promote DE&I, we celebrate diversity. To recognize the need and expectations related to flexible work arrangements, Veeda is breaking the mould on the 8 to 5 routine by offering flexible hours and has several roles where remote work and hybrid work models are permitted. A tech savvy organization is attractive for Gen Z while it also brings efficiency. This move towards leveraging technology is already built within the Veeda’s operations and as an example, Veeda has already implemented electronic data capture systems. We continue to invest in modern tools and platforms that facilitate collaboration and efficiency.
Personal development is another driver for GenZ. To meet this expectation, Veeda offers training programs, mentorship, and opportunities for career advancement to keep them engaged. Foster a culture of trust, transparency, and support. It is also important to ensure that employees feel valued and heard, which can significantly enhance job satisfaction and retention. To foster a sense of engagement with the talent, Veeda starts building relationships with potential candidates early through internships, campus recruitment, and online engagement. This helps create a pipeline of talent ready to join your organization.
By implementing these strategies, CROs can attract and retain top Gen Z talent, ensuring a dynamic and innovative workforce ready to meet the industry’s evolving challenges.
What would be your advice to budding leaders in the industry?
For budding leaders in the CRO industry, navigating the complexities and demands of this field requires a blend of strategic thinking, empathy, and continuous learning. Here are some key pieces of advice:
1. Embrace Continuous Learning: The CRO industry is constantly evolving with new technologies, regulations, and methodologies. Stay updated with the latest trends and advancements by attending industry conferences, participating in webinars, and pursuing relevant certifications.
2. Prioritize Patient Safety and Ethics: Always keep patient safety and ethical considerations at the forefront of your decision-making process. This not only ensures compliance with regulations but also builds trust with clients and participants.
3.Leverage Technology: Utilize modern tools and technologies to streamline operations and improve data management. Embracing digital transformation can enhance efficiency and accuracy in clinical trials.
4. Foster Collaboration: Encourage cross-functional collaboration within your organization. Building strong relationships with different departments can lead to more innovative solutions and efficient project execution.
5. Focus on Client Relationships: Building and maintaining strong relationships with clients is essential for long-term success. Understand their needs, provide exceptional service, and consistently deliver high-quality results.
6.Cultivate a Growth Mindset:
d) Be open to new ideas and approaches. Encourage your team to experiment and learn from failures. A growth mindset fosters innovation and resilience.
e) Effective communication is crucial for leading teams, managing client relationships, and navigating complex projects. Work on your ability to clearly convey ideas, listen actively, and provide constructive feedback.
f) Create an inclusive work environment where diverse perspectives are valued. This can lead to more creative problem-solving and a stronger, more cohesive team.
g) Invest in the growth and development of your team members. Provide opportunities for training, mentorship, and career advancement to build a motivated and skilled workforce.
h) The CRO industry can be challenging and unpredictable. Stay resilient in the face of setbacks and be adaptable to changing circumstances. This will help you navigate the complexities of the industry more effectively.
By following these strategies, you can position yourself as a strong leader in the CRO industry, capable of driving innovation and achieving success.
4. Regulatory Oversight: Trials must comply with regulatory guidelines, such as those from the FDA or EMA, which include specific requirements for ensuring patient safety. Even after the trial concludes, participants are often monitored for long-term safety outcomes to ensure that no delayed adverse effects occur.
These measures collectively ensure that patient safety is prioritized throughout the clinical trial process, ultimately leading to more reliable and ethical research outcomes.
What strategies should the leaders adopt to foster cross-functionality across the organization?
Fostering cross-functionality across an organization can significantly enhance collaboration, innovation, and efficiency. Here are some strategies leaders can adopt to achieve this:
1. Establish common goals, emphasize knowledge sharing, and build trust & transparency:
a) Align departmental goals with the overall organizational vision to promote collaboration. When everyone is working towards the same objectives, it encourages a unified approach.
Building strong relationships with different departments can lead to more innovative solutions and efficient project execution
b) Create open channels of communication and encourage regular knowledge sharing sessions. This can be facilitated through regular meetings, collaborative platforms, and internal newsletters.
c) Foster an environment of trust where team members feel comfortable sharing their ideas and feedback. Transparency in decision-making processes can also help build trust across different functions.
2. Embrace diversity and Invest in Technology: Encourage diverse perspectives and ideas from all team members, which can lead to more innovative solutions and a more inclusive work environment. Utilize collaborative tools and technologies that facilitate communication and project management across different departments.
3. Nurture staff development:
Skill enhancement and career growth are important aspects of leadership. These items lead to employee satisfaction and staff retention. One example of how this is implemented in Veeda is through cross-training. As a part of continuous learning programs, Veeda provides a knowledge-sharing platform wherein experts of different functions/departments share their knowledge and expertise. These sessions help identify talent movement opportunities.
4. Recognize and Reward Collaboration: Acknowledge and reward team members who demonstrate strong collaborative efforts. This can be through formal recognition programs, bonuses, or public acknowledgment in meetings.
5. Create leaders: Provide learning and development opportunities for leaders to manage cross-functional teams effectively. At Veeda, we invest in leadership development programs to train leaders to manage and facilitate cross-functional teams effectively.
6. Celebrate Milestones and Small Wins: Recognize and celebrate team achievements to build a positive team spirit. Celebrating small wins can boost morale and foster a sense of collective accomplishment. Sharing the successful completion of an important milestone such as the first patient should be used as an opportunity to communicate progress and for recognition.
Gen Z will be the largest working-age population, bringing their tech-savvy habits and unique healthcare needs. How do you attract top talent to the industry?
At Veeda, we take the approach that the employee is our biggest asset. Attracting top Gen Z talent to the healthcare industry requires a strategic approach that aligns with their values, tech-savvy nature, and unique needs. For Gen Z, it’s important that work has a purpose and can be impactful. Towards this ask, as a CRO, we are constantly affecting lives by contributing to advancing healthcare and improving patient outcomes. Another important value is that of Diversity, Equity, and Inclusion (DE&I). At Veeda, we look for opportunities to not just promote DE&I, we celebrate diversity. To recognize the need and expectations related to flexible work arrangements, Veeda is breaking the mould on the 8 to 5 routine by offering flexible hours and has several roles where remote work and hybrid work models are permitted. A tech savvy organization is attractive for Gen Z while it also brings efficiency. This move towards leveraging technology is already built within the Veeda’s operations and as an example, Veeda has already implemented electronic data capture systems. We continue to invest in modern tools and platforms that facilitate collaboration and efficiency.
Personal development is another driver for GenZ. To meet this expectation, Veeda offers training programs, mentorship, and opportunities for career advancement to keep them engaged. Foster a culture of trust, transparency, and support. It is also important to ensure that employees feel valued and heard, which can significantly enhance job satisfaction and retention. To foster a sense of engagement with the talent, Veeda starts building relationships with potential candidates early through internships, campus recruitment, and online engagement. This helps create a pipeline of talent ready to join your organization.
By implementing these strategies, CROs can attract and retain top Gen Z talent, ensuring a dynamic and innovative workforce ready to meet the industry’s evolving challenges.
What would be your advice to budding leaders in the industry?
For budding leaders in the CRO industry, navigating the complexities and demands of this field requires a blend of strategic thinking, empathy, and continuous learning. Here are some key pieces of advice:
1. Embrace Continuous Learning: The CRO industry is constantly evolving with new technologies, regulations, and methodologies. Stay updated with the latest trends and advancements by attending industry conferences, participating in webinars, and pursuing relevant certifications.
2. Prioritize Patient Safety and Ethics: Always keep patient safety and ethical considerations at the forefront of your decision-making process. This not only ensures compliance with regulations but also builds trust with clients and participants.
3.Leverage Technology: Utilize modern tools and technologies to streamline operations and improve data management. Embracing digital transformation can enhance efficiency and accuracy in clinical trials.
4. Foster Collaboration: Encourage cross-functional collaboration within your organization. Building strong relationships with different departments can lead to more innovative solutions and efficient project execution.
5. Focus on Client Relationships: Building and maintaining strong relationships with clients is essential for long-term success. Understand their needs, provide exceptional service, and consistently deliver high-quality results.
6.Cultivate a Growth Mindset:
d) Be open to new ideas and approaches. Encourage your team to experiment and learn from failures. A growth mindset fosters innovation and resilience.
e) Effective communication is crucial for leading teams, managing client relationships, and navigating complex projects. Work on your ability to clearly convey ideas, listen actively, and provide constructive feedback.
f) Create an inclusive work environment where diverse perspectives are valued. This can lead to more creative problem-solving and a stronger, more cohesive team.
g) Invest in the growth and development of your team members. Provide opportunities for training, mentorship, and career advancement to build a motivated and skilled workforce.
h) The CRO industry can be challenging and unpredictable. Stay resilient in the face of setbacks and be adaptable to changing circumstances. This will help you navigate the complexities of the industry more effectively.
By following these strategies, you can position yourself as a strong leader in the CRO industry, capable of driving innovation and achieving success.