Clinical Research is an important vertical of the Healthcare Industry that plays a critical role in the drug development lifecycle and helps bring much needed therapies for diseases impacting human life. There has been an evolution in clinical research from traditional methodologies to adapting to technology aiding better, safer, and more efficient clinical trials across the globe. In the landscape of clinical research, Advarra is a pioneer in providing integrated solutions for clinical research making impressive strides in the industry since its inception. Headquartered in Columbia, MD, Advarra's presence reaches across the globe with operating offices in Bengaluru, India.

Advarra is at the forefront of the most com - prehensive and important clinical studies, bringing together life sciences companies, CROs, research sites, investigators, and academia together at the intersection of safety, technology, and collaboration. With trusted review solutions, innovative technologies, services, experienced consultants, and deep-seated connections across the industry, Advarra provides solutions that safeguard trial participants, empow - erclinical sites, ensure compliance, and optimize research performance. In fact, Advarra supported 100% of Operation Warp Speed vaccine trials and is the market leader in regulatory review solutions, research quality and compliance consulting services and clinical technologies. Overall, Advarra’s mission is to advance clinical trials to make them safer, smarter, and faster.

Swetha R Khokale holds the office of Senior Director, Business Operations Services at Advarra and under her leadership, the team and the organization has not just been able to build a positive reputation but also create a niche for themselves in the industry.

In an exclusive interview with WOMEN ENTREPRENEUR, Swetha talks more about her journey in the clinical research industry and how she strives for sustained success.

Take Us Through Your Early Educational Journey And Prior Industry Experience That You Bring To The Table. What Motivated You To Develop Interest In Clinical Research Industry And Gain Expertise In This Field?

 I come from a family of doctors with my grandfather, father, and uncles all who were passionate about their profession prioritizing care for their patients above everything else. I was born and raised in Manipal and lived on the KMC (Kasturba Medical College & Hospital) campus where my father Late. Dr. S. S Raju was the HOD of Psychiatry during the 1980’s – 1990’s. Although it was a small town, I feel very fortunate and realize the importance of having had a progressive environment during my growing up years where all of us as campus kids were encouraged to do well academically as well as develop confidence and feel empowered to think of our goals and value our dreams at a very young age irrespective of gender, caste, or religion.

We moved to Ranchi where my father was the Director and Medical Superintendent of CIP (Central Institute of Psychiatry), one the oldest and largest psychiatry hospitals in the country. My father dedicated his life to revamping the hospital, providing better infrastructure, treatment to patients and best in class medical education at the institution. Well, life is not always a bed of roses and has its way of throwing major curveballs your way when you least expect it. My father passed away in 1998 when I was 15 and then had no choice but to face life head-on.

Things I learnt from that point onward till this day remains the driving force behind the principles I live by the choices that I make every day valuing the opportunity of life that we have been blessed with. I owe a lot to my mother, brother and my teachers at St. Anthony’s School, Ranchi and CSKM Public School, New Delhi for imparting solid values that has held me in good stead through all these years. After my school, I did not want to go down the traditional path of medicine and during the time, Biotechnology was very new in India. I was intrigued by the amalgamation of technology and healthcare which led me to take up Bachelor’s in Biotechnology from the Oxford College of Science, Bengaluru followed by Master’s in Biotechnology from Garden City College, Bengaluru.

When it came to making a career choice, I realized I was not cut out to work in a lab. I needed to be in a space where I could contribute to a direct aspect of patient care and development of new drugs. Clinical research was in its budding stage at that point in India and the more I read about, I was able to relate to it 100% and knew it was my calling. I did a PGD in Clinical Research and Data Management at ICRI, to study the subject in detail and be well equipped with the knowledge required to get started in the field.

I started out as a Clinical Research Associate with IQVIA, erstwhile Quintiles and interestingly the first project I worked on was in psychiatry on bi-polar disorder with KMC, Mani pal as one of the participating sites. It just felt right. The initial years was a lot of hard-work, burning mid-night oil, hectic travel, managing crises, firefighting timelines and importantly, invaluable learning’s from every project. We were a fabulous small team and the leaders we had were extraordinary and inspirational in more ways than one.

Over a period, I was fortunate to have worked on other facets of clinical research including quality, training, processes, technology, and core operations with end to end management of clinical trials across various regions and therapeutic areas at Parexel, ARIS Global and Navitas Life Sciences before joining Advarra.

What Are Your Roles And Responsibilities At Advarra? How Has Your Professional Experience Helped You To Achieve Positive Results For The Company?

At Advarra, I oversee operations of the Business Operations Services vertical fondly called the BOS team internally and by our customers. We are based out of Bengaluru, are100+ team member steam growing steadily and expected to increase 50% in strength by Q2 this year. We work with global sponsors, CROs, reputed hospitals, premier academic research centers, NCI designated cancer centers etc. We offer services that include CTMS solutions of setting-up protocol calendars, budget setup, budget negotiation, EDC study design, coverage analysis, ICF Development, e-Consent, e-Source builds, data migration, research staffing solutions  to name a few.

I feel blessed to be part of an amazing high performing team with exceptional leadership at the helm that believes in customer excellence, employee centricity, transparency and sustaining the wonderful work culture built over the years that truly define Advarra. The BOS team has built a solid reputation with our customers exceeding delivery expectations with excellent quality metrics. We have been able to positively impact the reduction in study start-up timelines, provide expertise and free-up site staff to help them focus on patient management and their core responsibilities. The nature of the services business is very dynamic and requires us to be always on our feet, adapt quickly to changes, new requirements, strategize and plan execution each month. Given these challenges, we adopted to processes that enable us to have better foresight, manage risks better, innovated to create dashboards and metrics to track progress effectively, reduce dependencies and bring about higher efficiencies in our day-today operations. The ability to think out of the box, being open to new ideas/feedback, investing in up skilling, and innovation has helped largely to bring about positive growth and traction from our customers.

We are at very exciting juncture not only at Advarra but the industry as such especially post COVID that has led to better adoption of technology, re-think clinical trial conduct in terms of decentralization, patient centricity and with the regulatory authorities being on board revising regulations, we are at the forefront of leading the pathway to better and faster development of new drugs and therapies.

What Are Some Of The Milestones In Your Professional Career That Gave You Utmost Satisfaction?

Success does not come over night and is not a destination but an ongoing journey. It is the small steps that we take and the efforts we put in each day that eventually culminates to successful bigger milestones. With that said, there have been several moments of personal gratification for me in my career. From working at the ground level, watching cancer patients thronging hallways of hospitals, willing to spend all their savings with the hope of treatment for their affected loved ones to being able to working on revolutionary oncology trials and seeing the drug make it through approval is an unforgettable experience.

Then, having the opportunity to work on different aspects of research especially technology,quality, leading multiple customer engagements and teams, driving initiatives to successful outcomes, strategizing and set-up business verticalsfrom scratch has  been part of this wonderful journey.

At Advarra, amidst the COVID-19 situation and despite all the challenges, with our amazing team, we were able to clock in 30% year on year growth.It was our time to give back to our customers and we helped them set-up close to 400 COVID-19 protocols with contributes to patient care and management of diseases and to be part of it one way or the other is a great feeling.

How Do You Keep Yourselves Updated With The Latest Industry Trends?

Clinical research is a remarkably diverse, highly regulated, and constantly evolving field. COVID-19 is one best examples of how there was a need to adapt to innovation, technology and collaborate with all stakeholders to ensure rapid development of the much-needed vaccines without compromising on quality and compliance. It is important to keep abreast of latest developments as well as ensure they translate to business as needed. At Advarra, we have a strong customer community that goes beyond business where we appreciate the contribution to research and therapies especially for unmet medical needs. The Onsemble conference that we host for our customers twice in year is a coveted event with the attendance of top-notch-medical professionals, industry experts, hospitals, and research centers in the US. Irrespective of the competitive field we are in, this is a platform that our customers love where they discuss current challenges, best practices, changes in regulations etc.

In India, I am a member of the Indian Society for Clinical Research (ISCR) for quite a few years now and have been part of many initiatives in including training sites, research staff, ethics committees etc. on regulations, clinical trial methodologies, best practices etc. along with help organizing conferences and workshops. ISCR is a non-profit consortium of key opinion leaders, industry experts across pharma companies, CROs, healthcare professionals and academia and has been a constant source of a wealth of experience and knowledge.

Can You Talk More About Your Leadership Style And As A Seasoned Veteran What Would Be Your Advice To Aspiring Women Entrepreneurs?

I believe integrity, vision, compassion, and excellence are the four cornerstones of good leadership. True to its meaning, a leader is someone who leads by example. As a leader, it is not just about driving our teams or organizations to achieve revenue or business goals but building a strong foundation of knowledge excellence, trust, quality, and customer focus to sustain as businesses grow and scale. To foster a culture of inclusivity, transparency, innovation, where the team is empowered to have a voice, feels valued, is recognized for their contribution and is given fair opportunities to thrive and grow professionally. One can only succeed as a leader if we have been able to inspire and build leadership within our teams. Striving to be a good and effective leader is always an ongoing process of learning, unlearning and evolving with change. I have been fortunate to work with exceptional leaders throughout my career and owe it to them to have played a key role in shaping me up as an empathetic leader.

Talking of women entrepreneurs, it is a topic very close to my heart and brings me great joy to se young women turning entrepreneurs or pursuing their passion in their professional careers. To begin with, we should start by believing in ourselves and know that we are fully capable of realizing our dreams and aspirations. As women of today, having received equal education and opportunities, it is extremely important to be financially independent not only for our ourselves but for our families and to be able to brave through adversities.

When making a business or career choice, passion is the key word. If you are passionate about your cause, something that you truly believe in, you will not only sustain the journey through troughs and crests, but the gratification when you reach your goals will be unparalleled. There are no short cuts to success. Be willing to put in the hard work with honesty and integrity each day and you will see the results coming back to you. Be open to learning, be well informed of developments in your area of expertise, value feedback, and be willing to take risks. It is always a good thing to be “Work in Progress” where you are constantly leveraging your strengths and working on areas of improvement. Be invested in the well-being, growth and development of people who work with you, they are your biggest assets. Strong work ethics is what helps build amazing teams and organizations.

Along the way as women, there will be challenging times as you try to balance your professional and personal lives, hang in there as it will pass, do not give up. Planning your day well, prioritizing quality time with your family and creating a strong support system especially if you have children as they grow-up is key. Some days you may not have it all, there will be breakdowns and that is perfectly normal. Tomorrow is always a new day with unlimited possibilities.

Swetha R Khokale, Senior Director, Business Operations

A pioneering individual who has an undying passion for clinical research. In addition to achieving business excellence and contributing to the new drug development landscape, she strives to create an inclusive working environment where her team members can thrive and become future leaders.