The Indian CRO (Contract Research Organization) Market was valued USD 970 million and is expected to reach by USD 1962 million with a CAGR of 12.7% during the forecast period. Forecast to 2025; Presence of diverse climatic conditions and acceptance of international guidelines and intellectual property rights are the key factors that fuel the market. Availability of largest pool of patients and large number of hospitals, educated and accessible human resources, and low operational cost due to cheap human resources are some of the other factors that boost the market to reach its target during the forecast period.
While medical science is on a constant quest to develop better and more effective treatments, prevent diseases and provide accurate cure to human life, Bengaluru headquartered ICBio Clinical Research aims at being a catalyst in this quest of advancing medical science forward.
ICBio is one among the Top 10 CRO’s of India. The company was incorporated in the year 2008 under the Company Act. ICBio’s drive toward international markets has grown with a specific focus on ROW sectors. The company has been rewarded Smart Bio Award by Govt of Karnataka, Pharma Ratna Award and also has won several Pharma Awards.
“We strongly believe in scientific excellence through teamwork and this has helped us rise to become one of the most competent partners for the (Bio) pharmaceutical companies across the globe. ICBio constantly strives to be a partner for the pharmaceutical world by bridging the gap of bringing a therapy from Lab to Shelf and thereby contributing towards achieving the human ambition of having a longer, healthier and happier life”, says Dr Harish S, Director, ICBio Clinical Research.
Know this CRO that Transcended Quality Service
ICBio is a full-service Contract Research Organization (CRO), providing comprehensive, quality & integrated data and an end to end clinical research solutions; Clinical Trials (Phase I-IV), BA (Bioavailability studies) / BE studies (Bioequivalence studies), Clinical Endpoint studies, quality clinical research solutions in India & across the world to its clients for studies ranging from PK studies in healthy volunteers to patient trials for generics and NCEs. ICBio is Inspected and approved by Drug Controller General of India (DCGI) CDSCO, India, ISP Chile, MOH Kazakhstan, and NABL Accredited Central laboratory integrated with LIMS.
The organization serves to Pharmaceuticals, Cosmetics, Personal care, OTC Products, Medical Devices, and Nutraceuticals & Herbals companies. ICBio Clinical Research is a 32 bedded clinical facility with fully access-controlled state-of-art and UPS back-up. In the near future, ICBio is opening another state-of-art 80 bedded clinical facility.
ICBio Conducted BA/BE studies for various regulatory agencies worldwide like USFDA, EU, ISP Chile, FDA Philippines, Vietnam, Tanzania, MOH Kazakhstan and all CIS countries The firm has been successfully doing many Clinical Studies for many Ayurveda, Herbal, Pharmaceutical, Nutraceuticals and Dermatology Companies around the Globe.
ICBio offer cost effective, result oriented studies for Bio analytical Services, PK / PD studies, Medical Writing, Biostatistics and Data Management, PSUR and Pharma covigilance services to clients according to their requirements. ICBio also provides Regulatory services like preparation of ACTD, CTD Dossier and DMF preparation for export / product registration.
All the services facilitated by ICBio are conducted in strict conformity with the latest ICH / GCP /CGLP and 21 CFR (part 11) and all other applicable guidance’s and regulations.
The total facility of ICBio is spread over 20,000 sq ft. with demarcated areas for dedicated activity
Volunteer Registration room, Clinical Pharmacological Units (CPU), Bioanalytical Laboratory, Clinical Trial Operations, Clinical Lab, Regulatory Affairs, Quality Assurance and Archival. i.e. ICBio’s clinical / Bio-analytical facility. The firm also has the latest ICP-MS Bio analytical instrument offering the sensitivity and the ability to conduct hormone studies etc.
Why ICBio is the Partner of Choice for Global Pharma Giants
Lack of CRO differentiation increases the cost of clinical development, slows the time to market entry and forces pharmaceutical companies to layer in management oversight. Sharing his insight on the dilemma, Dr Harisha S. says, “The simple truth is that pharmaceutical companies of all sizes need service providers today, more than ever. They need their resources, their global reach and, dare we say it, they need their clinical development experience and expertise.” Ideally, this industry primer will focus on the lack of differentiation among CROs today and the impact it has on pharmaceutical companies and the CROs themselves.
ICBio is a reliable CRO that provides end to end Clinical Study Services and caters to its Sponsor’s throughout the Study, after completion of Studies, with a one point contact for export solutions and regulatory support. That’s essentially, ICBio’s differentiating factor that sets it way ahead in the race. The success of a clinical trial is driven by the strategic selection of a reliable CRO. ICBio’s vastly experienced team of highly qualified professionals, a comprehensive portfolio of clinical research services to support diverse requirements and a robust Quality Management System guided and nurtured by ICBio’s quality culture makes the firm a partner of choice for some of the leading pharmaceutical companies in the world.
Achieving Data Integrity & Operational Excellence
Dr Harisha S. shares his rich knowledge of the domain, and explains that data integrity requirements have been addressed in the FDA’s Title 21 CFR Part 11 and the Data Integrity and Compliance With CGMP Guidance for Industry EU's GMP Eudralex Volume 4, Chapter 4 and Annex 11; and that it has remained unchanged so far. However, with increasing automation based on computerized systems, as well as the globalization of operations and the increasing cost of bringing products to market, new guidance was needed to clarify regulatory expectations around the creation, handling and storage of data.
Under his leadership, ICBio achieved the same via following measures:
• Perform Risk-Based Validation
• Select Appropriate System and Service Providers
• Audit your Audit Trails
• Change Control
• Qualify IT & Validate Systems
• Plan for Business Continuity
• Be Accurate
• Archive Regularly
ICBio conducted clinical trials, BA/BE studies for various regulatory agencies worldwide like USFDA, EU, ISP CHILE, FDA PHILIPPINES, VIETNAM, TANZANIA, MOH KAZAKHSTAN and all cis countries”
Operational excellence of ICBio organization is the execution of its operations in an excellent way, with better operational results, creating value for sponsors. The firm is strictly following integrated management system (IMS) and a culture of operational discipline. The first component, an IMS, consists of a framework of processes and standards that define where the organization is going, identify the risks, mitigate, manage change, and continuously improve.
The second component, a culture of operational discipline, is commonly described as doing the right thing, the right way, every time. This culture is built upon five guiding principles. Those principles are integrity, questioning attitude, level of knowledge, watch team backup, and formality. These values are used to identify the behaviors expected of each and every employee and how they support the organization's mission and outcomes.
Accounting to these parameters, Dr Harisha S. implies how ICBio strives its best to meet the Highest Quality, Economic Budgets, Speedy Timelines & Completeness of Study, and a preferred cost-effective CRO for global submission & ROW markets.
Future is what we make of the Present
ICBio is arguably one of the leading Independent CROs in India with a scientific edge, better foresight for Early to Late phase clinical trials & an objective of becoming a catalyst for enhanced drug developments to facilitate better patient treatments. With 13 years of vast experience, this CRO is serving a global clientele predominantly across Asia, Europe, USA India and CIS Countries. The team at ICBio has 60 plus dedicated professionals to deliver Quality Clinical Research solutions coupled with robust scientific expertise & excellent regulatory knowledge to help pharmaceutical companies deliver life-changing therapies.
“ICBio is a reliable CRO that provides end to end clinical study services and caters to its sponsor’s throughout the study, after completion of studies, with a one point contact for export solutions and regulatory support”
Sharing his thoughts on a ‘future’ roadmap, Dr Harisha S. explains, “I’d recommend not even attempting to plan too far in advance. This just means you end up planning and replanning constantly, and there are more constructive ways to spend your time. What I’ve found works best is reviewing the roadmap on a weekly basis, tracking progress and making tweaks where necessary. This means things don’t get out of hand and it’s essentially always ‘up-to-date’” He adds, “With respect to the PIE/ICE frameworks, we use ROI (Return-On-Investment) as guidance, which is similar and simply collapses the potential and importance into ‘expected return’”.
One thing is inevitable; under Dr Harisha S. guidance, ICBio, with the innovation speed and agility will enable more rapid idea development through a think big, start light, and scale fast mind-set.