D.T. Arasu, Founder & MD, 0
Established in 2009, iDD Research Solutions is India's fastest growing Contract Research Organizations(CRO). Based out of Chennai, iDD Research Solutions is the brainchild of D.T. Arasu, who himself is an industry veteran with over 15 years of expertise in this domain. CEO Insights has got this opportunity to interview, Arasu (Founder & Managing Director, iDD Research Solutions), where he shares brief insights into his professional journey and the growth of his firm from idea to implementation.
"I would not call it an advice to other, rather reminder to self.
Dream will look like Distraction..
Commitment will look like Adamancy..
Confidence will look like Ego..
Passion will look like madness..
Sincerity will look like stupidity..
Till you win...only till you win.."
Give us brief details about your educational and professional background. Also, tell us about your unique skill sets and strengths that differentiate you from your peers in the industry.
Having pursued B.Sc. in Mibrobiology, and Masters in Biotechnology, followed by MBA in Marketing & Six Sigma, I first started-off working as a sales person (Home Applinaces) during my college days. Later, I ventured my way into the clinical research (CR) industry in 2005. However, my entrepreneurial journey kicked-off with i5 (now iDD Research Solutions) when I was 25, and today, we have successfully completed 12 years now. Within this tenure, I ventured into seven other entities across different verticals with few flops as well. Most of these have been ventured during 2014-2018 when clinical trial industry was going through a tough phase. However, readjusting my focus on CR where my core interest lies, I revamped i5 as iDD with head offices in Minnesota, US in 2018.
In my 16 years of experience in the field of Clinical Research and healthcare, I have had an opportunity to involve myself in hundreds of studies in various roles starting from CRC to MD. These projects include both Global and National studies from various phases and types like Phase-II to IV, PMS, IIS, BABE, TE and POC, along with various indications starting from Oncology to Infectious disease, Neutraceutical, Cosmatic studies and device studies.
From developing India's first SDMO and revamping the same as CRO and Operating it successful for 12 years to building around 25 New Clinical Research Units across India with all basic requirements with respect to infrastructure, team, training, and regulatory aspects, we have come a long way.
And the learning I had from real life experiences and fellow human beings has been the biggest erudition I would say. With respect to professional experience, I have been fortunate to work with two great organizations like Apollo Hospitals (under Dr. Araham Oomman)and Synchron Research (Dr.Shiv in Synchron), Ahmedabad. These have been the real foundation, and it is backing me to run the show now.
Tell us about the vision and mission behind the establishment of iDD Research solutions? Being the fastest growing Indian CRO, how is the firm ahead of its competitors?
In the early 2009, when numerous SMOs were mushrooming across the country, the core business model of most SMOs was to mediate studied between CRO and Sites, which made the actual meaning of SMO as Site Mediating Organization from Site Management Organization. As a result, there was a huge gap with respect accountability of quality and control of the SMOs over the sites and studies. Moreover, the association between Doctors and SMOs has mostly become transitional. Hence, we, at iDD Research Solutions have deviated from this common business model and took a tougher approach, where it took us more than six months to convert every single centre into revenue generating mode, as we had association only with hospitals that have never been involved in clinical trial and started from scratch by setting-up facility, manpower, infrastructure and SOPs. This ensured that we could mould the quality process exactly the way we wanted, as there was no hangover of existing process and also had complete hold on the centres we developed. SDMO i.e. Site Development and Management Organization, has been a unique business model that has set us apart from the typical SMO model and given us the strong foundation, where in less than two years of our incorporation, we have around 35 centres across the country with more than 150+ active projects, which is the core reason why we could evolve from a SMO towards being world's First Digital CRO.
Today, even when we wanted to revamp i5 as iDD Research Solutions, we had continued the trend of differentiating from the crowd and started building our first fully integrated digital system in place, which is helping us to move ahead strongly in the journey to become world's first Digital CRO. To add to this, iSMART our flagship enterprise software is officially our first step towards it. When we started building iSMART in 2018, it was the time when specialized tools were the buzz of industry. But now, you can clearly see that the buzz word in industry is integrated tools. iSMART as a product is one of its kind and is first integrated, dynamic, flexible solution to remotely control study conduct and data recording at site level, which is developed on the concepts like e-Source, E-ICF, Digital protocol, Digital or virtual trials and having its control system as the crux to give the ultimate benefit in significantly reducing cost and time of drug development.
We believe, a product like iSMART has the potential to work as a tech enabler for Pharma companies to conduct multinational studies with much higher control on conduct and quality, at the same time with much lesser cost. Such tools open-up options of multiple regional CROs working collaboratively on a single multinational study from different region, as the quality of data and conduct of the study is driven by the technology then the regional process. We are very sure that, further of study conduct will be more tech driven by tools like iSMART and we are glad to be the pioneers in this.
How are you leveraging your experience and expertise to craft innovative solutions for iDD Research Solutions? Throw some light on your roles and responsibilities within the organization.
As the lead member of iDD Research Solutions, I feel it is my core responsibility to ensure that all our team members are happy at what they do, because I firmly believe that if we ensure our team is happy, their productivity will be a definite by-product. I believe, for any leader, it is important to identify the core skills of your team members and help them excel in it, because each and every individual has something called the core skill, which comes naturally to them. As a good leader, we must identify those and put them in the right space to explore it, which will definitely fetch excellent result with minimum interference. I always say this my role is not to manage, rather to assist my team in identifying their talents and give them right environment to work, and rest your team will take care of.
As far as contributing to the process, as I have been lucky to begin my career as CRC, which gave me strong hold on my basics and been lucky to explore all major roles in the ladder in the last 16 years. This has helped me in understanding the requirements and expectation of all stakeholders with full visibility while we work on the plans. The same has been very helpful in conceptualizing enterprises software like iSMART, which works as an integrated tool to connect all stakeholders involved the complete process chain of a clinical research.
Highlight upon iDD Research Solutions'journey so far. Also, what are the challenges that you have encountered since inception?
Our journey since inception has truly been leaning on multiple aspects and the learning only gets better with every passing day. We had an amazing evolution from being a SDMO to SCRO to CRO to now a Digital CRO and each & every evolution over the years has happened at the right time to ensure that we branch out bigger.
While our growth curves is similar to what all Clinical Research related Indian companies had gone through during the turbulent period due to regulatory uncertainty from 2014 to 2018, the moves we made during 2013 when we created a vertical called SCRO(SpecializedCRO), that focused mainly on non registered studies on products like neutra ceutical, cosmetic and herbal, helped us to create a solid backing for us during this turbulence and also worked as a perfect foundation to plan our biggest move of revamping i5 to iDD Research Solutions.
All our experiences over the years have helped us massively to create a strong foundation in place, especially when iDD revamp took place, where we had two parallel verticals functioning one focusing on conversational CRO model, and the other developing tech products for digital CRO concept (iTRIALs). Let it be the crazy scale-up of SDMO from one site in 2009 to 35 sites in less than two years or the current phase where we witnessed 3xgrowth constantly for last four quarters. This 12 years of journey has been amazing and we have to give credit to all i5ers from day-1, who have been showing commendable commitment towards pulling this off.
How do you see the current market landscape of Clinical Trials across India? What are the major gaps that you see in this domain? How is iDD Research Solutions addressing the existing gaps of Clinical Trials industry?
The recent streamlining and more favoring regulatory environment amid the pandemic situation has definitely led to the boom of Contract Research industry across India, thus drawing increased awareness towards the need for evidence-based (data) healthcare. With respect to gaps/challenges, one of the key challenges which any clinical trial faces globally is being able to complete the study within the planned time and budget, due to many key contributors such as recruitment & retention, quality of data, deviation rate, site compliance, to process and resource stability at sites and CRO.
At iDD Research Solutions, our iTRIALs concept has been developed with appropriate automation and real time data access to address some of the major issues at the right time. Most importantly, to avoid certain errors through our (to be patented) technology 'AI check' (a next generation edit check technology), we can almost eradicate the data entry error and qualify data at entry level, thus saving time and cost. iSMART the first product in our iTRIALs concept, is expected to have an impact on overall trials at all stages.
Also, for patients iDD Research Solutions have a tool named iPET, which is a cloud-based solution to revolutionize feasibility, study conduct and patient enrollment. i-PET facilitates global connectivity, allowing to achieve fastest ever feasibility survey/ study across the globe, and it enhances site performance with respect to recruitment by cross references and its unique patient enrolment process. We are constantly integrating lots of innovative technologies in right way to bring everything on one single platform.
Where is iDD Research Solutions positioned in the current clinical trial industry of India and what are your thoughts on the present and future scenarios of this space? Are you affiliated to any of the accreditation bodies?
Being one of the fastest growing Indian CROs, all the credit goes to the excellent team that we have. Starting from a new joinee to the ones in leadership position, you will see exceptional energy and commitment level across the ladder. Currently, our focus is to keep the growth rate going and for the conventional CRO model, we are now aiming to increase the international businesses to more than 50 percent of total business, which is currently around 20 percent. As mentioned above, the key shift in business is going to be our conversion as a Digital CRO fully, which we see happening in next two years.
About accreditations, yes we are an ISO 9001-2015 certified company and we are also the member in DIA. As far as quality is concerned, we stick to our core mantra 'By quality, Through Quality, For Quality'. The reason for having this as the mantra for this year is because we have revamped most of our process & systems, doubled our QMS team strength, and have also moved some of our best talents into QMS. Moreover, our processes are made in a way where our QMS becomes integrated part of all departments to ensure it works as a support system to control the process rather than a monitoring system to correct process errors.
As the Founder, what strategies are you devising to reach a stronger position in the Clinical Trial domain? What is the roadmap set ahead for iDD Research Solutions?
At iDD Research Solutions, we believe in a simple and straightforward strategy 'Stick to Process'. I have firm belief that if you stick to process, it will ensure that it takes care of all turbulence and short falls which are unavoidable in the journey. Process is very important for any industry, and when it comes to CRO industry, process maters the most. At iDD Research Solutions, we spend enough in making implementable process, creating systems to track process adherence and have robust review systems to ensure constant improvisation.
The current COVID-19 pandemic situation has definitely led to the booming of CR industry, and as far as iDD's business is concerned, from the operational perspective, we have seen 3x growth consecutively in last four quarters and expect to close with minimum 4x growth this year, in comparison to 2020. With full-fledged launch of iSMART, we are also in talks for collaboration/ mergers. We want to keep working towards creating a more favouring environment for healthcare & society. Going ahead, we are also aiming for a complete shift to pure Tech enabler/Digital CRO to empower the way clinical trials are conducted across the globe. Our move towards collaboration/merger is to muscle our self for the global launch of iSMART. I believe in a very simple principle'The only thing that is humanly possible is being sincere towards your attempts' and that's what I have been doing all these years and I wish to continue the same.
Key Management
Vairamuthu, Associate Director Project Management
Currently heading the business with iDD Research Solutions, Vairamuth has over 15 years of proven experience with rich expertise in Clinical Research domain, Risk based Monitoring, Site Management, Project Management, Team Management, Business Development and Process Improvement. Having worked with Medisys, IQVIA, Cognizant and ICON, Vairamuthu has been a part of about 60+ clinical trials in various indications. He has set up end to end process for risk-based monitoring and has also established for all the Clinical Studies.
Dr. Melvin George
Dr.Melvin has completed his DM in Clinical Pharmacology from JIPMER in 2012, after completing his MBBS and MD (Pharmacology) from the same institute. Currently working as an Associate Professor in Dept of Clinical Pharmacology at SRM Medical College Hospital & Research Centre, Chennai, Dr. Melvin is also a Consultant & Head, Clinical Research at Hindu Mission Hospital, Chennai. From investigating several clinical trials and observational studies including two multicentric registries in heart failure and COPD, Dr. Melvin George's has published 66 scientific papers in national and international journals and wight book chapters.
Dr. Bhaswati Mukherjee, Consultant Bio Statistics
Dr. Bhaswati has received her Ph.D. in Statistics from Banaras Hindu University, India and has got around 15 years of working experience in Statistics including University teaching and statistical consulting in the pharmaceutical industry. Having worked with multiple pharma companies, her current research interest is application of Bayesian methods and statistical simulation in clinical trial design.
Ishani Banik, VP-Biometrics
Ishani is the VP, Biometrics at iDD Research Solutions. A certified Lean Six Sigma Green Belt and a Biotechnologist by education, Ishani has 15 successful years of experience in some of the world's best Pharma and CROs. Her vast experience in leadership roles spans from first line to higher management leadership in functions like Clinical Data Management, Data Operations and Biometrics. Currently heading the Biometrics vertical of iDD Research Solutions.
Shilpa Agrawal, Head - Quality Management Initiatives
With over 15 years of Clinical Research experience, Shilpa joined iDD Research as Consultant in Jan 2019, and is currently heading the Quality Management Initiatives for iDD, including gap analysis, process improvement, Learning and Development, Compliance check, representing the organization during internal and external audits and inspections.
While our growth curves is similar to what all Clinical Research related Indian companies had gone through during the turbulent period due to regulatory uncertainty from 2014 to 2018, the moves we made during 2013 when we created a vertical called SCRO(SpecializedCRO), that focused mainly on non registered studies on products like neutra ceutical, cosmetic and herbal, helped us to create a solid backing for us during this turbulence and also worked as a perfect foundation to plan our biggest move of revamping i5 to iDD Research Solutions.
We believe, a product like iSMART has the potential to work as a tech enabler for Pharma companies to conduct multinational studies with much higher control on conduct and quality
All our experiences over the years have helped us massively to create a strong foundation in place, especially when iDD revamp took place, where we had two parallel verticals functioning one focusing on conversational CRO model, and the other developing tech products for digital CRO concept (iTRIALs). Let it be the crazy scale-up of SDMO from one site in 2009 to 35 sites in less than two years or the current phase where we witnessed 3xgrowth constantly for last four quarters. This 12 years of journey has been amazing and we have to give credit to all i5ers from day-1, who have been showing commendable commitment towards pulling this off.
How do you see the current market landscape of Clinical Trials across India? What are the major gaps that you see in this domain? How is iDD Research Solutions addressing the existing gaps of Clinical Trials industry?
The recent streamlining and more favoring regulatory environment amid the pandemic situation has definitely led to the boom of Contract Research industry across India, thus drawing increased awareness towards the need for evidence-based (data) healthcare. With respect to gaps/challenges, one of the key challenges which any clinical trial faces globally is being able to complete the study within the planned time and budget, due to many key contributors such as recruitment & retention, quality of data, deviation rate, site compliance, to process and resource stability at sites and CRO.
At iDD Research Solutions, our iTRIALs concept has been developed with appropriate automation and real time data access to address some of the major issues at the right time. Most importantly, to avoid certain errors through our (to be patented) technology 'AI check' (a next generation edit check technology), we can almost eradicate the data entry error and qualify data at entry level, thus saving time and cost. iSMART the first product in our iTRIALs concept, is expected to have an impact on overall trials at all stages.
Also, for patients iDD Research Solutions have a tool named iPET, which is a cloud-based solution to revolutionize feasibility, study conduct and patient enrollment. i-PET facilitates global connectivity, allowing to achieve fastest ever feasibility survey/ study across the globe, and it enhances site performance with respect to recruitment by cross references and its unique patient enrolment process. We are constantly integrating lots of innovative technologies in right way to bring everything on one single platform.
Where is iDD Research Solutions positioned in the current clinical trial industry of India and what are your thoughts on the present and future scenarios of this space? Are you affiliated to any of the accreditation bodies?
Being one of the fastest growing Indian CROs, all the credit goes to the excellent team that we have. Starting from a new joinee to the ones in leadership position, you will see exceptional energy and commitment level across the ladder. Currently, our focus is to keep the growth rate going and for the conventional CRO model, we are now aiming to increase the international businesses to more than 50 percent of total business, which is currently around 20 percent. As mentioned above, the key shift in business is going to be our conversion as a Digital CRO fully, which we see happening in next two years.
About accreditations, yes we are an ISO 9001-2015 certified company and we are also the member in DIA. As far as quality is concerned, we stick to our core mantra 'By quality, Through Quality, For Quality'. The reason for having this as the mantra for this year is because we have revamped most of our process & systems, doubled our QMS team strength, and have also moved some of our best talents into QMS. Moreover, our processes are made in a way where our QMS becomes integrated part of all departments to ensure it works as a support system to control the process rather than a monitoring system to correct process errors.
As the Founder, what strategies are you devising to reach a stronger position in the Clinical Trial domain? What is the roadmap set ahead for iDD Research Solutions?
At iDD Research Solutions, we believe in a simple and straightforward strategy 'Stick to Process'. I have firm belief that if you stick to process, it will ensure that it takes care of all turbulence and short falls which are unavoidable in the journey. Process is very important for any industry, and when it comes to CRO industry, process maters the most. At iDD Research Solutions, we spend enough in making implementable process, creating systems to track process adherence and have robust review systems to ensure constant improvisation.
The current COVID-19 pandemic situation has definitely led to the booming of CR industry, and as far as iDD's business is concerned, from the operational perspective, we have seen 3x growth consecutively in last four quarters and expect to close with minimum 4x growth this year, in comparison to 2020. With full-fledged launch of iSMART, we are also in talks for collaboration/ mergers. We want to keep working towards creating a more favouring environment for healthcare & society. Going ahead, we are also aiming for a complete shift to pure Tech enabler/Digital CRO to empower the way clinical trials are conducted across the globe. Our move towards collaboration/merger is to muscle our self for the global launch of iSMART. I believe in a very simple principle'The only thing that is humanly possible is being sincere towards your attempts' and that's what I have been doing all these years and I wish to continue the same.
Key Management
Vairamuthu, Associate Director Project Management
Currently heading the business with iDD Research Solutions, Vairamuth has over 15 years of proven experience with rich expertise in Clinical Research domain, Risk based Monitoring, Site Management, Project Management, Team Management, Business Development and Process Improvement. Having worked with Medisys, IQVIA, Cognizant and ICON, Vairamuthu has been a part of about 60+ clinical trials in various indications. He has set up end to end process for risk-based monitoring and has also established for all the Clinical Studies.
Dr. Melvin George
Dr.Melvin has completed his DM in Clinical Pharmacology from JIPMER in 2012, after completing his MBBS and MD (Pharmacology) from the same institute. Currently working as an Associate Professor in Dept of Clinical Pharmacology at SRM Medical College Hospital & Research Centre, Chennai, Dr. Melvin is also a Consultant & Head, Clinical Research at Hindu Mission Hospital, Chennai. From investigating several clinical trials and observational studies including two multicentric registries in heart failure and COPD, Dr. Melvin George's has published 66 scientific papers in national and international journals and wight book chapters.
Dr. Bhaswati Mukherjee, Consultant Bio Statistics
Dr. Bhaswati has received her Ph.D. in Statistics from Banaras Hindu University, India and has got around 15 years of working experience in Statistics including University teaching and statistical consulting in the pharmaceutical industry. Having worked with multiple pharma companies, her current research interest is application of Bayesian methods and statistical simulation in clinical trial design.
Ishani Banik, VP-Biometrics
Ishani is the VP, Biometrics at iDD Research Solutions. A certified Lean Six Sigma Green Belt and a Biotechnologist by education, Ishani has 15 successful years of experience in some of the world's best Pharma and CROs. Her vast experience in leadership roles spans from first line to higher management leadership in functions like Clinical Data Management, Data Operations and Biometrics. Currently heading the Biometrics vertical of iDD Research Solutions.
Shilpa Agrawal, Head - Quality Management Initiatives
With over 15 years of Clinical Research experience, Shilpa joined iDD Research as Consultant in Jan 2019, and is currently heading the Quality Management Initiatives for iDD, including gap analysis, process improvement, Learning and Development, Compliance check, representing the organization during internal and external audits and inspections.