This week’s contribution to ’52 Perspectives’ comes to us from Jacquie Mardell and Radhika Bobba, the founding partners at Anhvita Biopharma Consulting Pvt Ltd. Jacquie and Radhika provide professional training to all levels of clinical research professionals using real-world applications from their 45 years of industry experience.
1. What are some steps your company takes to identify the correct resources for your clients to make the clinical trial process go smoothly and successfully?
Personal knowledge of our resources is very important to us. We have to be able to put our reputations behind any resource we connect the client to. Our goal is that each client has full confidence in the clinical trial resources we bring to the table.
2. How do you ensure that the subjects in clinical trials have a good general understanding of the research being done to them?
Education is the key to ensuring that patients have to opportunity to make a well-informed choice to participate in a trial. In all cases it is up to the clinical investigator to provide the patient with the right pieces of information in the right amounts. Government plays a role by providing a framework for consent, a set of essential elements that, if properly presented, can give the patient sufficient information to decide whether participation in a trial is a good idea for her. At Anhvita, we provide professional training in the consent process for CRO and investigator staff to protect and enhance the patient’s right to make an informed decision.
3. Does the Indian government play a role in educating citizens who participate in clinical trials? How?
In India, the government is keenly aware of the wave of clinical trials rapidly approaching its shores over the coming years. The government is also aware of the vulnerability of some of its citizens in the consenting process and addresses this by ensuring rigorous regulatory and ethical review processes. Unlike some emerging clinical trial countries, India does not simply adopt wholesale US and EU requirements but has created many protections that are specific to its position as one of the premier destinations for clinical trial outsourcing.
4. What does your company do in clinical trial documentation and analysis that increases success for new drug approvals?
Documentation is one of the keys to ensuring good data quality – if it isn’t written down, it probably didn’t happen. In our experience we have seen firsthand how a well-organized, well-written dossier can smooth the regulatory process. We have also seen how sponsors’ applications for clinical trial approval and for marketing permission and be hampered by poorly written submissions and clinical trial reports. At the clinical trial level, we work to ensure that the necessary elements of the trial are clearly and properly documented so that the trial files are clean, orderly and the regulated events of the trial are clearly traceable by the auditor.
5. How is the current US economic struggle hurting or helping clinical trial conduct in India?
The US economic downturn has had the effect of shutting off the flow of resources at the faucet, i.e., at the level of Big Pharma. With Big Pharma holding onto its cash for the better part of a year, the smaller biotech and device companies have had to deploy their resources more wisely and find lower cost ways to generate the high quality data they need to command a good price for their technology. When we look to sources of high quality, motivated and treatment-naïve patients, we look at the emerging markets of India, Central and Eastern Europe and other parts of Asia. India poses strong advantages to these clients due to its premier position in that marketplace. Anhvita helps sponsors connect to the services and patients that India offers to generate high quality data.
About Anhvita Biopharma Consulting Pvt Ltd:
Anhvita provides solutions that: connect sponsors with qualified investigators and tailored clinical and regulatory services in India and other emerging markets; seek out and deliver important clinical trial business to Indian investigator and site networks; and provide professional training to all levels of clinical research professionals using real-world applications from our own 45 years of experience.
To contact Jacquie and Radhika please Click Here
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ok. i’ve resisted twitter until now. I’m curious by nature.