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India is emerging as a country with tremendous potential to contribute to the national and international clinical trial platforms. The Central Drugs Standard Control Organization (CDSCO) is the national regulatory authority of India managed by the Drug Controller General of India (DCGI).1,2,3 The DCGI is responsible for the coordination of inspections of the sponsors, manufacturing units, as well as the trail sites.3

Early years in clinical development

In 2000, the Indian Council of Medical Research (ICMR) set up ethical guidelines for conducting biomedical research on human subjects.4 The year 2005 saw revision of Schedule Y of the Drug & Cosmetics acts, 1945, to align Indian regulatory laws to definitions and procedures that are internationally accepted. The changes included:

  • •Defining Phase I to Phase IV of a trial
  • •Demarcated responsibilities of sponsor(s) and investigator(s)
  • •Options to record any deviation or changes to the approved study protocol

India also signed the trade related intellectual property rights (TRIPS) agreement in 2005 in order to open up the prospects for conducting more clinical trials in India.5 Apart from harmonizing the regulatory acts to international standards, India quickly became a favorable destination for clinical trials as it offered:6

  • •English-speaking professionals in health care
  • •technical expertise
  • •growing economy
  • •world-class technology
  • •large, diverse, and treatment-naïve population


Set Back for clinical trials

Despite changes in the regulations, many multinational pharmaceutical companies took advantage of the large population that had either inadequate knowledge about clinical trials or were illiterate. In addition, an ill-defined health care system added to the challenges of monitoring unethical practices. This led to conducting clinical trials with little supervision and no recording of patient informed consent either in written or as audio/visual content. Patients were administered investigational drugs or devices without disclosing known serious adverse effects, some leading to death of the subjects. Moreover, no independent enquiry committee was set up to ascertain if the death of patient was related/not related to the investigational product or device.4

The years 2010 to 2013 saw a trying phase in the Indian clinical trial scenario due to the accumulated ill effects of conducting unethical trials. However, with a better regulatory framework in place, the Clinical Trial Registry of India (CTRI) has recorded a steady rise in the number of trials being conducted as seen in Figure 1. It was also observed that most of the trials were phase III trials.7

 

Figure 1
Clinical trial trends over the years
8

Figure 2 presents the state-wise distribution of trials in India between 2007 and 2015. Approximately, 3330 trails were registered during this period. It was observed that maximum number of trials was conducted in Maharashtra and the least number of trials was conducted in the Northeastern state. Among the Northeastern states, no trials were conducted in Nagaland.7

Figure 2
State-wise distribution of clinical trials in India (2007-2015 data)
7


Revival of the clinical and regulatory scenario

In 2014, the CDSCO has constituted 12 new drug advisory committees (NDAC) and 25 subject expert committees (SECs). These committees have a number of experts from eminent government colleges and institutions to expedite the approval timelines of a clinical trial to 6-7 months. The three-tier process consists of:9

 

However, only the SEC reviews global clinical trial applications and no further approval is required from the Technical committee or the Apex committee. Investigational new drug (IND) applications are also reviewed independently by the IND committee and do not require the approval of the Apex committee. A Technical committee comes into picture only if the SEC has rejected a sponsor’s application and the sponsor feels aggrieved by the decision. In such an event, if the Technical committee disagrees with the decision of the SEC, it has the power to overrule the decision of the SEC.10

In March 2019, the Ministry of Health and Family Welfare, India released the New Drugs and Clinical Trial Rules 2019 with the intention to fast track the approval for clinical trials, new drugs, bio-equivalence (BE), or bio-availability (BA) studies. These rules have also addressed any ambiguity that existed with respect to the regulation of Ethics committee (EC).11

 


Highlights of the New Drugs and Clinical Trial Rules, 201911

Updated rules and regulations11

Approval timeline for clinical trials

90 working days from receipt of application for drugs discovered outside India and 30 working days for new drugs or IND in India

Manufacturing of new drugs or IND, BE & BA studies or test analysis or examination

Permission is required from the Central Licensing Authority (CLA)

Waiver of local clinical trials

· If CLA has approved marketing of the new drug in other countries or has granted permission to conduct global clinical trials for the new drug in India
· No evidence of difference in metabolism, safety or efficacy owing to difference in the genetic profile of the Indian population

Period of validity of a clinical trial

2 years from date of issue by CLA

Post-trial access to IND or new drug

In unique circumstances, the drug is to be distributed free of cost to trial subjects per the direction of CLA, but no liability lies with the sponsor for use of drug after trial.

Pre-submission and post-submission meetings

To seek guidance with respect to law and procedures that governs the process of manufacturing and licensing or granting permission.

Approval for trials conducted by EC and registration of EC

· Approval to be obtained from EC of another trial site if trial site does not have an EC and the EC should be within 50 kms of the trial site.
· CLA approved registration of EC remains valid for five years from the date of issue.

Conditions to be fulfilled for conduct of clinical trial

· Submission of status report on a quarterly basis or depending on the duration of trial to track subject enrolment
· Online reporting of the status of the clinical trial every six months via SUGHAM portal to know if the trail is ongoing or completed or has been terminated.

Fee for procuring license, certificate of registration and permission for trial

Different fee structures depending upon the purpose of the trial. Fee ranging from INR 50,000 to 5,00,000.

Bridging the gap

The challenges of dealing with clinical trials are multi-faceted and involve abiding of the regulatory framework in a responsible and ethical way by stakeholders, government, and judicial system alike.


Patient safety and protection
 should be of utmost importance laying strict rules for:12

  • •informed consent by audio-visual recording and in a language that the patient is comfortable with
  • •respect for the patients cultural, social, economic, and educational background
  • •timely reporting of SAEs


New ground rules
 that can open up the possibility of expanding medical research in India are:13

  • •approval of proposals submitted to the DCGI within 30 days of application, if there is no communication from the DCGI
  • •fast tracking of domestic approvals
  • •pre and post submission meetings with the expert committee to bring in more transparency to the process and to set a well-defined timeline for trial completion
  • •trial compensation in case the investigational drug led to SAEs/death.


Proficient work force and state-of-art infrastructure
 also play an important role in attracting sponsor companies. Research has demonstrated that though Phase III trials are being conducted in a big way in India, Phase I trials seem to be limited to the sponsor country. This could be attributed to the Sponsor’s apprehension in procuring qualified work force and technology. To enable indigenous research to happen in India, it is pivotal to provide appropriate exposure or continuing medical education to personnel and access to up-to-date technology to be recognized as a country competent enough to conduct any phase trials.9

Equally important is the need for skilled health care workers to be available throughout the country to account for the uneven distribution of clinical trials across states. Concentrating a trial on a particular state could lead to biased conclusions and oversimplify or exaggerate a disease burden or condition. By providing access to people in all states to join a clinical trial, we not only minimize bias but also include diverse, ethnic populations.9

The future

With positive, patient-friendly, fast track, and transparent regulatory laws, India will continue to grow as an international hub for testing and developing innovative medicines and medical devices.


Sources

1.Evangeline L, Mounica NVN, Reddy VS et al. Regulatory process and ethics for clinical trials in India (CDSCO). The Pharma Innovation Journal. 2017;6(4):165-9. http://www.thepharmajournal.com/archives/2017/vol6issue4/PartC/6-4-4-176.pdf

2.Lahiry S, Sinha R, Choudhary S et al. Paradigm Shift in Clinical Trial Regulations in India. Indian Journal of Rheumatology. 2018;13:51-5.

3.Gogtay NJ, Ravi R, and Thatte UM. Regulatory requirements for clinical trials in India: What academicians need to know. Indian Journal of Anaesthesia. 2017 Mar;61(3):192-9. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5372399/

4.https://www.emich.edu/chhs/hs/documents/clra_final_projects/clinical_trials_in_india_history_current_regulations_and_future_considerations.pdf Accessed on April 23, 2019

5.Ramu B, Kumar M S, and Ramakrishna N. Current Regulatory Scenario for Conducting Clinical Trials in India. Pharmaceutical Regulatory Affairs. Open Access. 2015;4:2. https://www.researchgate.net/publication/281765214_Current_Regulatory_Scenario_for_Conducting_Clinical_Trials_in_India

6.Burt T, Sharma P, Dhillon S et al. Clinical Research Environment in India: Challenges and Proposed Solutions. Journal of Clinical Research Bioethics. 2014;5:6. DOI: 10.4172/2155-9627.1000201

7.Chaturvedi M, Gogtay NJ, Thatte UM. Do clinical trials conducted in India match its healthcare needs? An audit of the Clinical Trials Registry of India. Perspectives in Clinical Research. 2017;8(4):172-5.

8.http://ctri.nic.in/Clinicaltrials/news/CTRI_Newsbulletin_July-Dec_2017.pdf Accessed on April 23, 2019.

9.Bhave A and Menon S. Regulatory environment for clinical research: Recent past and expected future. Perspectives in Clinical Research. 2017;8:11.6.

10.https://novotech-cro.com/novotech-update-india-streamlines-clinical-trial-approval-process-and-reduces-regulatory-timelines. India streamlines clinical trial approval process and reduces regulatory timelines. Novotech Update. July 2017 Accessed on April 23, 2019.

11.Key Highlights of New Drugs & Clinical Trial Rules, 2019. Accessed on April 23, 2019

12.Dan S, Karmakar S, Ghosh B et al. Digitization of Clinical Trials in India: A New Step by CDSCO towards Ensuring the Data Credibility and Patient Safety. Pharmaceutical Regulatory Affairs: Open Access. 2015;4(3): DOI: 10.4172/2167-7689.1000149.

13.https://www.thehindubusinessline.com/news/new-rules-sweeten-the-deal-for-clinical-trials-by-indian-pharma-cos/article26283499.ece Accessed on April 23, 2019.

Disclaimer:

The information contained on this article is intended solely to provide general guidance on matters of interest for the personal use of the reader, who accepts full responsibility for its use. Accordingly, the information on this article is provided with the understanding that the author(s) and publisher(s) are not herein engaged in rendering professional advice or services. As such, it should not be used as a substitute for consultation with a competent adviser. Before making any decision or taking any action, the reader should always consult a professional adviser relating to the relevant article posting.

While every attempt has been made to ensure that the information contained on this article has been obtained from reliable sources, Veeda Clinical Research is not responsible for any errors or omissions, or for the results obtained from the use of this information. All information on this article is provided “as is”, with no guarantee of completeness, accuracy, timeliness or of the results obtained from the use of this information, and without warranty of any kind, express or implied, including, but not limited to warranties of performance, merchantability and fitness for a particular purpose. Nothing herein shall to any extent substitute for the independent investigations and the sound technical and business judgment of the reader. In no event will Veeda Clinical Research, or its partners, employees or agents, be liable to the reader or anyone else for any decision made or action taken in reliance on the information on this article or for any consequential, special or similar damages, even if advised of the possibility of such damages. No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form or by any means, mechanical, electronic, photocopying, recording or otherwise without the prior written permission of the publisher.


For information, contact us at
:

Veeda Clinical Research Private Limited

Vedant Complex, Beside YMCA Club, S. G. Highway,

Vejalpur, Ahmedabad – 380 051,

Gujarat India.

Phone: +91-79-3001-3000

Fax: +91-79-3001-3010

Email: info@veedacr.com

V-KONNECT with Mr. Jayanta Mandal

Veeda through its V-Konnect series interacted with Mr. Jayanta Mandal and discussed about “Current Outlook for contract research drug development Segment”

About the V- Konnect

V-Konnect interview series, is a program to get in touch with specialized industry experts to know their views on opinions on current relevant subject matters.

About Mr. Jayanta Mandal


Mr. Jayanta Kumar Mandal, M.Pharm has 20 years’ experience in Pharma R&D, IPR & business development. Worked in top 10 companies in India. Lastly headed R&D, Patent cell and Pharmacokinetic cells and managed product selection, all BE and CT studies for the company for all regulated and semi regulated markets. Also actively involved in business development for dossier and toll manufacturing bus

Mr. Mandal has wide range of experience in developing Immediate Release, Sustained Release, MUPS Oral formulations, Liquid and Lyophilized oncology and general Injectable products, Topical Dosage forms, Ophthalmic Dosage forms and Liquid Oral Products through s NDA, ANDA, DCP, Pellets, MRP and national procedures. Mr. Mandal has experience in dealing with US and EU patent attorneys and counsels for patent opinion, document discovery, deposition etc.

Below are the interview questions.

1. What do you think are the most important reason of the pharmaceutical companies for outsourcing the drug development to the CRO’s?

A: All big pharma companies cannot cover all products through them in house R&D. There are also failures during drug development and priority for the company to select the important projects relevant for their intended market. The companies having in house development with huge infrastructure in place also demands the use of CRO’s for their efficient and cost effective delivery. Up gradation of old MA’s, life cycle management, fill in the gap of pipe line for the business of pharma companies also looks for a quick solution toward the CRO’s. Virtual companies do not have facility or in house capability to develop projects and hence CRO’s fill the gap for all these companies.

2. How do you see Contract Research Industry Growth year on year and CAGR in next five years?

A: There are pressure working in all segments of pharmaceutical industry and CRO’s are not immune to that. The price and ever demanding regulatory pressure is increasing the cost of development the tough phase is expected to be over sooner. Industry consolidation through merger and acquisition also creating pressure on CRO’s. It is difficult to predict YOY CAGR growth in terms of % but we expect it to be lower than 15 % for next 2-3 years. Only the best will grow at more than 20 %.

3. Which therapeutic segments do you see have business potential across Indian CRO’s?

A: CRO’s are neutral to therapeutic area and work on demand basis. Only the regulatory limitation even in R&D for Betalactam, cephalosporin etc. limits the CRO to work in these space if they do not have separate R&D space for these classes. However, we see a surge in potential or interest in oncology segments and Injectable dosage form development as oral segment is crowded.

4. What strategies should Indian CRO’s adopt to nullify competition from International CRO’s?

A: Speed to develop and to retain the cost advantage will keep Indian CRO’s ahead of others. We have an advantage on language and requisite skill for pharmaceutical development. Be it chemistry, clinical or Pharmaceutics. The skill set is there prevalent in most part of India. The regulatory steps or clearances required for R&D is longer in some part of the country which needs to be made faster and more efficient. Another factor which will make Indian CRO’s more competitive is to have in house scaling up facility of local govt. standards to reduce time line for pilot BE studies. The investment needed to do that is high for most of the CRO’s and hence alternate regulatory framework is required to address this to retain our CRO’s competitiveness.

5. How do you visualize Contract Development of Biosimilars with CRO’s and what are the challenges associated with the same?

A: Research and Development on Biosimilar is a cost intensive process which requires high initial investment with long term ROI. It also requires good knowledge of Biology besides chemistry and pharmaceutical technology. More close collaboration with universities for biology/biotech competency needs to be developed as a robust streamlined process to have Biosimilar research to progress. We lack this at present moment which needs to be addressed. The area of contract research is the future of CRO as more and more biologics are coming into the market and more in pipe line. In next 20 years, more and more gene therapy and targeted therapy will be the norm and there is good future for Research companies who embarked on the Biologics space to get first mover advantage.

6. Do you feel the Need of more contract research organization in India and why?

A: There are thousands of pharmaceutical companies, diagnostic companies and biotech companies operating in India and for Indian market besides serving regulated, semi regulated and ROW markets. The world is moving more towards harmonization of regulatory requirements for drug, diagnostics and biologics approval process with few local variations. Current CRO’s have developed over last 3 decades mostly to cater to the need of regulated market. The space of CRO’s for regulated markets are likely to shrink due to proliferations of CRO’s in last 10 years and consolidation of end user companies.

The good news for CRO’s is implementation and up gradation of cGMP norms in domestic market where the approval process will require bioequivalence study submission and more vigilant regulatory agencies through their upgraded infrastructure, man power to implement the cGMP in the industry.

I feel the Indian market will give more growth in medium term for CRO’s

7. Looking at the failures of Clinical Trials and BE studies what is your view on the scientific expertise and knowledge of contract research organization that can provide support to the Pharmaceutical companies in this areas?

A: For any pharmaceutical product be it NDA or ANDA, expertise in both pharmaceutical technology and clinical/pharmacology (kinetics/dynamics) is important. Both go hand in hand as the expertise of drug product to absorb comes from pharmaceutics whereas how it is absorbed, distributed and eliminated eliciting response is in the domain of clinical /medical experts. As the biological variations in drug disposition due to inherent nature of patients/persons and drugs cannot be predicted accurately or controlled, the combined expertise of CRO’s and pharmaceutics will make a long way to resolve the challenges associated with drug development failure of clinical trials and BE studies.

8. How do you see growth of early phase and late phase clinical development by CRO’s in the upcoming years?

A: I do not see a high growth in early phase or late phase clinical development by CRO’s for classical chemical based drugs due to transitional change in therapy towards biologics and future targeted gene based therapies. Most of the classical early or late phase development of drugs will be shifted more towards mid-size and Venture capital funded companies. Biological clinical development programs will drive the growth in this segment for next 2 decades

On a closing note, Mr. Mandal added that “As our industry is linked with human beings very closely for its physical and mental health, the industry will always be regarded with respect. The pace and technology of growth will need to be matched with other industries dealing with health to be relevant. Artificial intelligence is likely to change the way healthcare industry currently works in all aspects. AI will change the way diagnostics are used, prescriptions are made and dispensing is done. So is the drug research and development. I believe that AI will change the way we use animals or human beings in drug development will likely be shifted more towards AI based technologies”.

Disclaimer:

The opinions expressed in this publication are those of the Interviewee and are not intended to malign any ethic group, club, organization, company, individual or anyone or anything. Examples of analysis performed within this publication are only examples. They should not be utilized in real-world analytic products as they are based only on personal views of the Interviewee. They do not purport to reflect the opinions or views of the VEEDA CRO or its management. Veeda CRO does not guarantee the accuracy or reliability of the information provided herein

Challenges in Biosimilar development.

Introduction

With patents expiring for many successful biologic drugs, researchers are focusing on developing drugs that are competitive in pricing and affordable to patients who require critical medications for managing chronic diseases.

A biosimilars medicinal product is a replica of the innovator medicinal product with similar safety and efficacy profiles.1,2. Some of the popular biosimilars are monoclonal antibodies biosimilars for cancer therapeutics, erythropoietin biosimilars, insulin biosimilars, interferon biosimilars, granulocyte colony-stimulating factor biosimilars, and human growth hormone biosimilars.

Small molecules versus large molecules

Small molecules are chemically synthesized and are simple, well-defined molecules. They can be characterized fully and have highly predictable functions. On the other hand, biologics are large molecules that are protein based and synthesized from highly complex biological sources. As living systems are used in the manufacturing of biologics, the process requires sound technological expertise.

Despite large molecules posing problems such as extreme sensitivity to process and handling as well as immunogenicity, their proven efficacy and precision in targeted therapy is making biologics popular in the treatment of many non-communicable and chronic diseases such as blood disorders, cancer, inflammatory diseases, and diabetes.4

Current Scenario of Biosimilars

Approximately 32 biologics will lose patent rights by the year 2019, the combined sales of which is estimated to be around $ 51 billion.6 However, developing biologics is a tedious and complicated process with many of the products taking approximately 10 to 15 years to come into the market.7 Studies have indicated that the market will continue to grow at a rate greater than 20% due to increase in the incidence of chronic conditions leading to increased utilization of biologics.8

Figure 1 presents some blockbuster biologics that face patent expiration or have already expired in EU and USA.


Figure 
1 Blockbuster drugs and year of patent expiration9

 

Patent expiration of a number of best-selling biologicals opens the door for the approval of biosimilars versions of the original products. These biosimilars are usually 20-30% cheaper than the innovator product. The European Union (EU) has approved more than 20 biosimilars since they provided their consent to use the first biosimilars, somatropin, in 2006.10

It is anticipated that the global biosimilars market will cross $35 billion by the year 2025 with a compound annual growth rate (CAGR) of 33%.11

Figure 2 shows maximum biosimilars development in the fields of inflammatory diseases and oncology.


Figure 2 Percentage of biosimilars development in different therapeutic areas12

Challenges in developing Biosimilars


➔  Difference in regulatory approval processes between countries
:

In EU, the interchangeability of a biosimilars does not require additional regulatory evaluation if the biosimilars demonstrates similar activity as the original product with no additional risk to the patient. However, this is not acceptable by the US regulatory body that mandates complex and costly trials to demonstrate interchangeability of a biosimilars. In addition, USFDA limits the use of extrapolation of data. The additional regulatory requirement not only increases the timeline for biosimilars development but also increases the cost and impedes the manufacturers enthusiasm in pursuing biosimilars in the long run.3,13,14


➔  Development and Timelines Challenges:

It is estimated that the cost of developing a biosimilars can go up to $ 100 million with a development time of 5-9 years, excluding the cost of failure.15 The Pharmaceutical Research and Manufacturers of America (PhRMA) estimated the cost of developing a biosimilars to be approximately $ 375 million as compared to $1.2 billion to develop a new biologic. However, the development timelines for a biosimilars are relatively shorter than that of a biologic. The Phase I and Phase III stages for a biosimilars can be shortened while the phase II stage can be skipped due to the established therapeutic efficacy and safety of the biologic.16


➔  Clinical challenges:

Immunogenicity is a potential risk with biosimilars. Hence, stringent risk management plans and post marketing surveillance of the drug should be in place to monitor any adverse events.13,17 Another challenge is patient acceptance of biosimilars due to limited knowledge or awareness about such products. Concerted efforts have to be made to ensure that the patient understands the basic principles of a biosimilars and its ability to exert therapeutic efficacy at much lower costs than their biological counterparts.18

➔  Analytical challenges:

The physiochemical and structural comparability of biosimilars with the original product is difficult due to their inherent heterogeneity. Analytic techniques such as mass spectroscopy, chromatography, or electrophoresis can be used to address some of the hurdles by: 13,17,19

☉  Comparing biosimilars lots against a reference product to assess the pharmacokinetics and pharmacodynamics of the biosimilars.

☉  Understanding multiple mechanism of actions involved by in vitro characterization

☉  Choosing of bioassay should be a case-by-case decision depending upon the specificity and sensitivity of the biosimilars.


➔  Commercialization and marketing challenges:

Major pharmaceutical companies sometime block other small players from producing biosimilars by creating restricted distribution agreements leading to unavailability of the innovator product sample. In addition, patents are abused to prolong the monopoly of a brand name thereby delaying patient access to more affordable and life-saving biosimilars.13

➔  Establishing concrete guidelines for market approval:

The USFDA and regulatory bodies of other countries are yet to establish streamlined guidelines for marketing approval of biosimilars.3,13,14

The way forward

➔  Biosimilars manufacturers can promote optimization by:5

☉  building trust and confidence between the payers and providers by reimbursement for biosimilars and providing cost-saving alternative solutions for long-term treatment.

☉  engage with the regulatory authorities during the early stages of development of biosimilars to capture their interest.

➔  Enabling extrapolation of data by regulatory authorities of the country is one of the crucial steps that can push the development of biosimilars. This in turn helps establish fair market trade.5

➔  Contract research organizations (CROs) can lend expertise to sponsor companies:20

☉  to develop a holistic, tailor-made and optimal clinical development plan (CDP) without losing focus on the commercial aspect of the business

☉  by using therapeutic and regulatory expertise, real world data, and market access strategies to influence access to biosimilars and to establish competitive pricing.

➔  By forging strategic global alliances and enhancing their expertise in biosimilars development.

Conclusion

Advanced manufacturing processes, limiting of patent litigations, and change in physicians and patients’ perception towards biosimilars can mitigate the current level of complexity and ambiguity involved in promoting biosimilarss.10 In addition, the overall cost of biosimilars can also be reduced by involving more number of players, these measures will allow for safer and wider access of biosimilars products to patients around the globe.


Disclaimer:

The information contained on this article is intended solely to provide general guidance on matters of interest for the personal use of the reader, who accepts full responsibility for its use. Accordingly, the information on this article is provided with the understanding that the author(s) and publisher(s) are not herein engaged in rendering professional advice or services. As such, it should not be used as a substitute for consultation with a competent adviser. Before making any decision or taking any action, the reader should always consult a professional adviser relating to the relevant article posting.

While every attempt has been made to ensure that the information contained on this article has been obtained from reliable sources, Veeda Clinical Research is not responsible for any errors or omissions, or for the results obtained from the use of this information. All information on this article is provided “as is”, with no guarantee of completeness, accuracy, timeliness or of the results obtained from the use of this information, and without warranty of any kind, express or implied, including, but not limited to warranties of performance, merchantability and fitness for a particular purpose. Nothing herein shall to any extent substitute for the independent investigations and the sound technical and business judgment of the reader. In no event will Veeda Clinical Research, or its partners, employees or agents, be liable to the reader or anyone else for any decision made or action taken in reliance on the information on this article or for any consequential, special or similar damages, even if advised of the possibility of such damages. No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form or by any means, mechanical, electronic, photocopying, recording or otherwise without the prior written permission of the publisher.


For information, contact us at:

Veeda Clinical Research Private Limited

Vedant Complex, Beside YMCA Club, S. G. Highway,

Vejalpur, Ahmedabad – 380 051,

Gujarat India.

Phone: +91-79-3001-3000

Fax: +91-79-3001-3010

Email: info@veedacr.com