Today's Top Gainer
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This report contains financial review, opportunities, challenge, outlook etc. i) FINANCIAL REVIEW:
Income earned to the extent of Rs. 2,640.13 lakhs as against Rs. 2,016.91 lakhs of previous year and earned a profit of Rs. 137.35 lakhs as against Rs. 30.54 lakhs compared to last year. ii) PERFORMANCE:
During the year under review your company recorded a turnover of Rs. 2,640.13 Lakhs as against Rs. 2,016.91 Lakhs for the previous financial year. The turnover is mainly from the core Clinical Research Services. The Business plan is to ensure at least two fold growth in business in the coming year(s) with the stable business. During the Financial Year under report, Clinical Research Services division has expanded into offering the complete portfolio of services as explained below: Jeevan has the advantage of fully integrated scientific expertise team in Clinical research functions. Jeevan started offering a varied range of clinical research services like Bioavailability/Bioequivalence studies and Phase I to Phase IV services to pharmaceutical and biotechnology industries. The technical team at Jeevan has immense experience in handling various projects in diverse therapeutic areas for different regulatory authorities. The leadership team at Jeevan has over 200 years of cumulative experience in this arena, which comprises successful execution of more than 2500 clinical research projects for several pharmaceutical clients across the globe. a. Bioanalytical Research:
Bioanalytical research laboratory is designed with state of the art facility equipped with advanced analytical instrumentation having 2 processing labs and 4 LC-MS/MS labs, which can accommodate up to 12 LC-MS/MS. During this financial year, your company acquired a total of 10 LC-MS/MS systems and these were added over the period to accommodate maximum possible work. Jeevan Scientific offers a unique combination of highly trained workforce enabled with well-equipped bioanalytical research and development (R&D) laboratory. Your bioanalytical laboratory located at Hyderabad is performing well and faced several successful regulatory and client audits.
b. Clinical Operations:
Being BA/BE studies are prime focused JSTL offering services, JSTL built a facility for executing the clinical phase of the BA/BE studies. In this regard, Jeevan established its clinical pharmacology centre in Hyderabad at B-17, TIE, Phase II, Balanagar, , Hyderabad, Telangana 500037. This facility is spread over 20,000 sft and distributed in the 2nd, 3rd and 4th floors of the building. This facility accommodate a total of 132 beds distributed in to 4 clinical pharmacology units with bed capacity of 42(Clinic 1), 24(Clinic 2), 42(Clinic 3) and 24(Clinic 4). This facility also consists of special care areas (3+3 beds), emergency lift, tie-up with tertiary care hospital and a dedicated ambulance to handle emergencies. This facility is capable of carrying out approximately 200 studies per year at a peak capacity. During this financial year, your company completed a total of 110 studies, which was an optimal growth for a facility with an age limit of 2 years. Experienced, trained medical and para-medical staff conducts all these studies at this facility as per GCP and applicable regulations. The facility is in compliance with all the statutory requirements and also the applicable regulatory requirements like Drug Control General of India (DCGI). This facility being used to carry out the BA/BE studies for pharmaceutical companies who are developing molecules for global market.
c. Clinical Trials and Trial Management:
Jeevans Clinical operation team has a vast experience in executing clinical projects of different therapeutic areas across the globe. Jeevan has rich pool of clinical investigators experienced in handling various phases of clinical projects including Pharmacokinetic and Pharmacodynamic studies. The Project management team oversee the technical and administrative aspects of the study. The team is committed to ensure timely update of project status, and meeting the client requirements in agreed timelines.
d. Regulatory Services:
Jeevans Scientific Medical Writing team is structured with a team of competent writers, with diverse portfolios. The team is currently supporting major pharma clients across the globe, to achieve their objectives in Regulatory & technical documents writing. Jeevan provide expert services for the management of concerns with regulatory authorities and fulfill client expectations in a realistic and transparent manner.
e. Clinical Data Management and Statistical Analysis Services:
The Data Management team has hands on experience in handling clinical data, and the team ensures efficient and reliable management of the data in compliance with industry standards and regulatory requirements.
f. Pharmacovigilance Services:
Jeevan scientific offers a wide range of comprehensive pharmacovigilance and safety monitoring services. Jeevans aim at a rapid pace growth, and retains an experienced vigilance team, thus being able to provide a wide range Pharmacovigilance services for different regulatory bodies. Currently your company is woring with a about eight clients in this area. During this financial year, your company could able to take advantage of the experience of this pharmacovigilance services and initiated a good number of contracts with small and medium pharmaceutical companies across USA and India.
A. AN IMPORTANT MILESTONE:
World Health Organization (WHO) auditors conducted an audit of our clinical pharmacology Centre and Bioanalytical facilities. The purpose of this audit was to review the BA/BE studies conducted and submitted by our sponsor to USFDA, WHO and MOH, South Africa. The auditors audited the facilities for a total of 4 days. We are please to inform that the auditors were satisfied with our procedures and processes which resulted with Nil Critical Observations.
USFDA auditors conducted an audit of our clinical pharmacology centre. The purpose of this audit was to review the BA/BE studies conducted and submitted by our sponsor to USFDA. The auditors audited our facilities for a total of 8 days. We are pleased to inform you that the auditors were satisfied with our procedures and processes which resulted with Nil 483 Observations. The earlier USFDA audited resulted with one 483 was also closed with verification of documents submitted to USFDA, the product got approved and an Establishment Inspection Report (EIR) also submitted.
With the above inspections completed, your facilities are audited by USFDA (3 times), CDSCO (4 times) and WHO (1 time) and there were no outstanding observations/matters with the respective regulatory authorities.
Your Company could visualize increasing opportunities in exploring new avenues in Clinical Research Services. The marketing efforts of the company received an encouraging response. Today there is an ample business for Clinical Research Services in India and abroad. The quality based infrastructure and manpower are not easily available in the market. Due to these strengths with Jeevan we are able to see lot of opportunities coming to Jeevan. Further your company successfully completed stringent regulatory inspections like USFDA, WHO and CDSCO and we are expecting to have more and more opportunities in the area of clinical research services.
Your Company faces normal market competition in all its business from domestic and overseas companies. However, our business strategies and global competitive cost position have enabling us to retain the market position and maintain operating margin and enhance long term, even under difficult operating conditions for the IT industry, Pharmaceutical Sector is going to play a vital role in increasing the revenues of the organization. We endeavor to enhance its competitive advantage through a process of continuous improvements and by implementing appropriate business strategies.
D. Advantages of CROs in India
None of the following advents of India changed drastically to have a competitive edge over other organizations located outside India and India is considered as the hub for the clinical trial industry and where in we provide the Clinical Research Services.
India offers a set of advantages that are so unique and strong vis-a-vis other regions of the world that no major drug research company can afford to ignore India in their medium to long term.
Ability to conduct a trial faster than most of the major locations in the world in most of the significant therapeutic segments. In this industry, time is money in true sense. In a study by Ernst & Young, it was concluded that in most cases there is a 20%-30% time advantage of carrying out a Phase III study in India compared to undertaking it in North America or in Western Europe.
India has a huge pool of subjects/ patients (many of them are treatment- nave) with wide spectrum of diseases that are willing to participate in clinical studies. The past experience has shown that in most of the multi country trials, patient enrolment is rapid in India, thereby speeding up the drug development process. The 20-year clock on drug patent starts ticking when a new compound is discovered, not when it is approved. An early completion of drug testing results in the reduction in cost incurred on its development and provides more time for selling it as a monopoly product enabling better recovery of costs incurred as well as earning good profits.
English is the main language of communications in the hospitals in all major cities. Carrying out a study in India in strict accordance with global guidelines results in cost saving of between 25-40% when compared to the regions mentioned above. India has a talented pool of Clinical Research Professionals (highly trained medical professionals) and infrastructure, which includes all super specialties of Medicine. Importing clinical supplies has become easier. An import license is granted with the clinical trial permission.
Apart from cost advantage, the more promising and long-standing advantage is the speed of recruitment/completion of trial that enables the drug developer to have longer time in the market before expiry of the patent to fetch the obvious benefits.
IT enabled infrastructure at a lower cost.
In the recent past, the efficient regulatory system in the country, enabling to attract more business from abroad in the area of clinical research.
The outlook for margins in current scenario will depend upon global demand and supply trends in the pharmaceutical industry. We intend to extend our client base and explore the new avenues and opportunities by entering in to tie-up arrangements with more national and International pharmaceutical companies.
E. ADEQUACY OF INTERNAL CONTROL:
Your company has internal auditors to ensure that internal control systems are in place and all assets are safeguarded and protected against loss. An extensive program of Internal Audit and reviews supplement the internal control systems by management & documented policy guidelines and procedures. The internal control systems are designed to ensure that the financial records are available for preparing financial statements and other data and maintaining accountability of assets.
The QA team is focused on continual improvement of Quality Management System and reports directly to management. QA auditors are armed with knowledge on national, international regulations and guidelines. The QA team audits quality systems and studies, carried out by Jeevan, in accordance with set procedures and applicable regulatory guidelines, to ensure fulfillment of quality requirements. Our Motto is to ensure total Customer Satisfaction. Proactive efforts are directed towards determining customers requirements and achieving all round customer satisfaction. This is primarily achieved through automated systems, high attention to complaint resolution online communication and information exchange, quality circles and adoption of programs.
G. HUMAN RESOURCES DEVELOPMENT (HRD):
Yours is a young Company, with human resources of an average age of 30 years for its employees as on March 31, 2019. Right from the beginning the company got good HR policies for retaining manpower. Your company employs a total of 200 people with good qualifications and high technical background and experienced in the area of work where they are in.
H. LEARNING & TRAINING:
Training programs have been devised to develop cross-functional skills and is a continuous process across functions and throughout the organization.
Enhops Solutions Pvt. Ltd. in India and Enhops, Inc., USA are fully owned subsidiary companies of Jeevan Scientific Technology Limited, Hyderabad. Enhops has clients across the globe USA, UAE, Saudi Arabia, UK & India and clientele includes organizations from start-ups to Fortune 500 companies.The analysts forecast the global software testing services market to grow at a CAGR of 15.1% during the period 2018-2022.
Enhops Service Offerings include Quality Assurance, Quality Engineering, Quality solutions and Test advisory & consulting.
Enhops traditional offerings include, Test Advisory Services: Todays digital business world demands high-quality products and services. Organizations should invest in innovation and quality assurance for their software and applications to stay ahead of their competition. They need a reliable software-testing partner who can assess their testing requirements, refine QA practice and advise on a QA roadmap in line with their business needs. Test Automation: Traditional software testing approaches, including manual testing, are not enough to rapidly deliver software with impeccable quality. Hence, test automation has gained lot of prominence in the recent times. Also, agile-driven software development and test practices have made test automation as an integral component of continuous integration and testing for continuous delivery.
Performance Testing: Todays hyper-connected world across mobile phones, smart devices, diverse media channels, and business applications demand enterprises to offer seamless end user experience so as to achieve competitive advantage. The slightest application downtime can put the reputation of an enterprise at stake and cause substantial revenue loss. Hence, testing of such business-critical applications/software requires a different perception entirely by putting customer experience at the centre. Security Testing: Data security is becoming extremely critical with more and more technological innovations happening in the industry. Security breach can happen at network level, system software level, client-side or server-side. Enhops Security Testing Services helps our customer to develop and secure their web or mobile applications as well as meet applicable regulatory and compliance requirements.
Mobile testing: Usage of mobile devices and applications has seen tremendous growth in the recent past. They are considerably enabling businesses and customers to interact in a whole new format. This exponential growth in the mobile market is bringing in new testing challenges with variant platforms, OS versions, screen sizes and networks. Test Cenre of Excellence: Some of the common testing challenges we see in an organization are ambiguous requirements, aggressive schedules, limited budgets for testing, complex environments, high operations costs and so on. Test Centre of Excellence (TCoE) is a centralized testing function established to address these challenges effectively and meet testing needs of all business units successfully.
DevOps: Industry recognizes the need for continuous integration and deployment. Without bringing testing into the mainstream development lifecycle, DevOps is incomplete, leading to quality issues.Organizations are looking to adopt DevOps to reduce Build to Deploy time. DevOps framework integrates development and operations with focus on continuous integration and testing to cut down the cycle time. The framework encompasses testing at various levels such as ambiguity reviews of individual user stories, testing at individual sprint level and complete end-to-end testing at the release level.
Functional Manual Testing: Early testing brings lot of benefits in terms of quality, time and cost. Static and dynamic testing goes hand in hand to make this happen. Involving testing teams in requirement workshops helps in understanding the expectations and build required tests soon.
Process Framework Establishment: Enhops brings its vast experience and expertise to establish a robust test methodology that will offer benefits through unified test governance, standardization and reusability. Our proprietary Global Delivery Methodology is used as basis to establish process framework at our client locations. handled as change requests and are addressed based on the priority assigned.
CORE: CORE is a homegrown methodology to establish and maintain Test Center of
QuesT: QuesT is an online questionnaire management tool, which is used for Test
EstiMate: EstiMate tool uses the industry standard PERT three-point estimation and test point analysis technique to understand the complexity and estimate effort.
KnoRA: Enhops KnoRA tool helps in managing requirements ambiguity analysis and reporting ambiguous requirements.
OptiTest: OptiTest is Enhops proprietary tool that supports test data generation for
Orthogonal array testing.
QGuage: QGuage is Enhops dashboard management tool that helps in generating customized metric reports and dashboards as per the requirement.
PrediQT: PrediQT is Enhops statistical prediction model that helps in predicting defects based on historical data.
CaIRoI: Enhops Automation ROI analyzer is an effective and simple way to understand the benefits derived automation at defines intervals.
Focus Areas in the Year 2019 - 2020
Enhops has embarked into next generation technologies & testing offerings keeping in mind the latest trends in the QA & QE industry.With the advent of Agile and DevOps development technologies, the software development industry is undergoing major disruptions. This has lead to the evolution of new testing approaches that Enhops has acquired and Enhops is focusing on the following trends to stay ahead in the competition,
1. Digital Transformation with Agile: Businesses are undergoing digital transformation ever since data has become valuable in gaining insights. The latest addition to this trend is the adoption of agile methodology to undergo a digital transformation. As digital transformation is an ongoing process, agile helps to deliver valuable outcomes frequently for the business rather than waiting for a long time.
2. Machine learning in testing: Machine learning is bringing about revolutionary changes in workflows and processes. In testing, machine learning can be used for Test suite optimization, Predictive analytics, Log analytics, Traceability, Defect analytics
3. Increasing Adoption of DevOps: In DevOps, the testing begins at the beginning of the development cycle. This development approach facilitates Continuous Integration and Continues Delivery. This allows testers to perform Continuous Testing and Continuous Monitoring to validate that the developers have built the right application. The functionality and performance of the application are tested continuously along with development.
4. Big Data Testing: Big Data is the high volume of data generated at a high velocity. In Big Data testing, testers have to verify that terabytes of data are successfully processed using commodity cluster and other supportive components. This type of testing focuses on performance testing and functional testing.
5. IoT Testing: There are more connected devices than ever before as IoT (Internet of Things) technology is gaining traction. IoT testing is conducted to test IoT technology based devices. The various types of testing for IoT systems are Usability Testing, Compatibility Testing, Reliability & Scalability Testing, Data Integrity Testing, Security testing, Performance Testing
6. Performance Engineering: Performance engineering will replace performance testing in the near future. Rather than executing performance test scripts, the focus will be on analyzing how all the elements of the system work together. The various elements of the system include performance, security, usability, hardware, software, configuration, business value and the customer.
7. Test Automation: The test automation helps the testing team to focus their time and efforts on creating test cases rather than managing testing needs. Test automation helps to track and manage all testing needs, the types of testing required along with the test coverage. Test automation helps to ensure high- quality software is delivered.
8. Combining Manual and Automated Testing: More and more quality assurance professionals are using a combination of manual and automated testing approaches to harness the benefits of both as well as to overcome their respective shortcomings.
9. Shortening Delivery Cycle: Rapid changes in technologies, platforms, and devices are putting pressure on software development teams to deliver the finished products faster and more frequently. Testing needs to be integrated with development to facilitate delivery. Software organizations are ready to invest more in improving their development and delivery processes by employing the right set of tools.
10. Integration: With shortening delivery cycles, there is a greater need for integration of various elements of a product development. To facilitate smart testing and analytics, the data is collected from disparate sources such as requirement management systems, change control systems, task management systems, and test environment.
Enhops is one of the few independent testing organizations who is utilizing AI & ML in software testing. ML and AI are undeniably growing to be significant elements in software testing and QA as well. AI will advance accuracy, give enhanced revenue and lower costs for all QA processes. Henceforth, it improves competitive positioning and customer experience. Most importantly, AI helps identify bugs quicker and faster. Enhops is one of the few testing companies who has embarked into this journey.