newsletter_aurouspeak_vol 01 ed 02 - aurous healthcare cro
TRANSCRIPT
The quarterly newsletter from the Corporate of Aurous HealthCare - CRO….
Dec 2013 Vol. 01 Ed. 02
Since 2008…Since 2008…
PROPRIETARY OF AUROUS HEALTHCARE R&D INDIA PRIVATE LIMITED
© Aurous HealthCare R&D India Private Limited, 2008, All Rights Reserved
The pioneer Contract Research Organisation (CRO) with focus on Clinical Research
http://auroushealthcare.wordpress.com/dr-vt-sriraam/
From the Desk of MD……... It has been an eventful year in the sphere of clinical research. Our industry has been under the
scanner by media and general public for reasons both the right and wrong. Nevertheless, light burns bright
at the end of the tunnel, with the Government bringing reforms and streamlining the process of clinical
research in the country.
Every food and fruit we consume, the anti-aging cream and nourishing shampoo we use, every
tablet or syrup that is prescribed touches and changes the life of a human being in some way. Given that
the balance of disease-disorder versus treatments is not much in our favor, it is mandatory that the
products are researched upon in ethically allowable, controlled environments as in clinical trials.
Clinical studies help save lives. Enable doctors and researchers to make informed decisions about
treatment modalities. Help us predict adverse reactions. Reinforce the safety and efficacy of home remedies
and herbal medicines that have been handed down to us through generations. Worldwide, members of
various governments are establishing reforms, guidelines and mandates, that does go to show that such
studies are indispensible when it comes to the overall better and healthy living of mankind. Hopefully the
new year will bring prospects that are brighter and more focused towards that goal!
My hearty wishes for a healthy, happy and successful new year!!!
With Best Regards, Dr. VT. Sriraam MBBS MD (Pharmacology) ManagingDirector | Medical director—Aurous HealthCare– CRO **************************************************************************************************************
Dr. VT. Sriraam MBBS MD (Pharmacology) is the founder– director of Aurous HealthCare - CRO. An alumni of Stanley Medical College, he was honored as ―The Best Doctor” by the Ministry of Health, Maldives at the age of 23. Gaining rich and varied experience at top CRO, Dr. VT. Sriraam founded Aurous HealthCare in 2008. An astute technocrat, his sharp business sense combined with his rich knowledge and experience in the field of clinical research has pushed Aurous HealthCare from strength to strength. He was recently shortlisted as one of the TOP 9 Innovative Entrepreneurs for CavinKare’s Chinnikrishnan Innovation Award 2013. A man with strengths so varied and unique, Dr. VT.Sriraam is the epitome of the entrepreneurial combination of business brains and clinical-research creatives.
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Inside…Inside…
AURO Ayur………………...………..…Page 4AURO Ayur………………...………..…Page 4
Malarial Vaccine Trial………..…Page 5Malarial Vaccine Trial………..…Page 5
AURO BYTE………………...………..…Page 5AURO BYTE………………...………..…Page 5
Risk based monitoring………..…Page 6Risk based monitoring………..…Page 6
AURO Days………………...………….Page 6AURO Days………………...………….Page 6
Exercise = Drugs………...………..…Page 7Exercise = Drugs………...………..…Page 7
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Send a test mail and receive quarterly updates
on Clinical Trials and Drug Research in your
inbox!
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Register!Register!
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ETHICS COMMITTEE ETHICS COMMITTEE
REGISTRATION IN INDIAREGISTRATION IN INDIA
On 8th February 2013, DCGI officially announced the
III Amendment to the Drugs and Cosmetics Act , 1945; and with
RULE 122DD , the CDSCO mandated the registration of Ethics
Committees all across the country.
A welcome move by researchers across the country, this
was seen as the one of the most positive moves by the CDSCO in
streamlining the process of clinical research in India.
Apart from the Scope of an Ethics Committee, Appendix
XII of Schedule Y elucidated the Composition of EC - member
details, quorum requirements, gender and educational balance
and representation along with resolution of conflict of interest;
Application Information - constitutive and administrative de-
tails of the EC.
Every functioning Ethics Committee in India was
required to submit an elaborate application to the office of DCGI,
which included information about constitution, composition of
the committee inclusive of member appointment, terms of
reference, replacement and resignation procedures.
Elaborate details of the clinical trial proposals reviewed
by the committee thus far along with their Standard Operating
Procedures and documentation regarding approvals, minutes of
meetings, reviews and audits of investigator sites were also
required to be submitted to the DCGI.
The initiative thus gave way to the registration and
approval for functioning of ethics committees as Independent
EC or Institutional EC. Each of these committee registrations
came with their own rules and stipulations from the office of DCGI
The process has been stringent and demanding, but
we at Aurous HealthCare Aurous HealthCare are happy and proud to share
the information that our Universal Ethics Committee Universal Ethics Committee
has been registered with the office of DCGI - CDSCO holding
the registration number
ECR/125/Indt/TN/2013, ECR/125/Indt/TN/2013,
with a validity of three years from
Oct, 2013. (continued on Page #4)
AURO BLOG!!!AURO BLOG!!!
For details ...Page 8 For details ...Page 8
www.auroushealthcare.com
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AURO Ayur…AURO Ayur…
Chavya - Stem of Piper nigrum
Sanskrit : Cavika
Assamese : Chepaan
Bengali : Chei
English : Java Long Pepper
Gujrati : Chavka, Chavaka
Hindi : Chavya
Kannada : Chavya
Malayalam : Kattumulaku,
Kattumulakunveru
Marathi : Chavaka ; Oriya : Chainkath; Punjabi : Chabak
Tamil : Chavyam, Chevuyam; Telugu : Chevyamu
Urdu : Peepal Chab, Kababah; Malayalam: Amalpori, Chuvanna
Medicinal uses:
Helps in proper secretion of bile juices from liver.
Beneficial in treating hemorrhoids and fistula.
Corrects metabolic issues and thus aids in weight loss.
of the cornea.
Ayurvedic Properties and Action:.
Rasa: Katu
Guna: Laghu, Rukha, Tiksna
Virya: Usna
Vipaka: Katu
Karma: Bhedana, Dipana, Kaphahara, Pacana, Recana,
Vatahara.
Dose: 1-2g of the drug in powder form. Ref : The Ayurvedic Pharmacopeia of India - Part I - Volume II
Clinical Trial Management Services Clinical Trial Management Services
Aurous HealthCareAurous HealthCare–– CRO:CRO:
AHC provides a complete package of comprehensive trial
management services for End to End Clinical Projects -
for New Chemical Entity, Chemical Entity, Herbal
Medicines, Nutraceuticals, Cosmeceuticals - through
our Clinical Trial Project Management services inclusive
of contracts, budget management, logistics control and
coordination, Vendor management, Site Management
Services for the successful completion of the project in-
cluding Clinical Study report. We also offer
exclusive Site Management Services.
Contact : [email protected] Contact : [email protected] or at +91or at +91--98409091559840909155 We also offer Clinical Trial Rescue Services to help mend strained Sponsor—CRO relationships, issue analysis at Clinical Trial Site, Medical monitoring services and independent quality
Continued from Page #3
The following are some of stipulations laid down
from the office of DCGI for Ethics Committees across
the nation.
The stipulations for review and approval of
clinical studies.
The mandates for reporting of Serious Adverse
Events as per Schedule Y of D & C Act.
The inspection of the administrative records &
functioning of the Ethics Committee by Drug
Inspectors from both State and Central Office of
CDSCO.
Maintenance of records (hard & soft copies) for a
period of 5 years.
Member constitution, Quorom requirements and
mandatory information to the DCGI about change in
composition.
Issues and resolution of conflict of interest during
an ethical review and approval.
This move from the CDSCO is seen as the first of the
most important decisions in streamlining the
process and system of medical research in India.
This will pave way for ethical clinical studies and
safer tested products in the market!
ETHICS COMMITTEE ETHICS COMMITTEE
REGISTRATION IN INDIAREGISTRATION IN INDIA
AuroQuiz answers: 1.B 2.B. 3. James Lind - Scurvy Trial www.auroushealthcare.com
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AURO Byte… AURO Byte…
http://prodom.prabi.fr/prodom/current/html/http://prodom.prabi.fr/prodom/current/html/
home.phphome.php
ProDom is a comprehensive database of protein domain families
generated from the global comparison of all available protein sequences. Recent improvements include the use of three-
dimensional (3D) information from the SCOP database; a completely redesigned web interface visualization of ProDom
domains on 3D structures; coupling of ProDom analysis with the Geno3D homology modelling server; Bayesian infer-
ence of evolutionary scenarios for ProDom families. In addition, ProDom-SG, a ProDom-based server dedicated to the
selection of candidate proteins for structural genomics has also been included.
PARENTS UNAWARE OF MEDICAL RESEARCH OPPORTUNITIES FOR THEIR CHILDREN …
To improve healthcare for children, medical research that involves kids is a must. Yet, only five percent of parents say their children have ever participated in any type of medical research, according to a new University of Michigan C.S. Mott Children's Hospital National Poll on Children's Health. In the poll, nearly one-half of parents said they are will-ing to have their children take part in research that involved testing a new medicine or a new vaccine, if their child had the disease being studied. More than three-quarters of parents are willing to have their children participate in research involving questions about mental health, eating or nutrition. The poll surveyed 1,420 parents with a child aged 0 to 17 years old, from across the United States. According to the poll, parents who are aware of medical research opportunities are more likely to have their children take part. But awareness is an issue: more than two-thirds of those polled indicated that they have never seen or heard about opportunities for children to participate in medical research. Five percent of families with children participating may not be enough to support important research efforts that the public has identified in previous polls - things like cures and treatments for childhood cancer, diabetes and assessing the safety of medications and vaccines. But the results indicate that a much bigger percentage of the public does understand the importance of medical research to advancing healthcare for children. This poll shows that the research community needs to step up and find ways to better reach parents about opportuni-ties for children to participate, answer parents' questions about benefits and risks of participation, and potentially broaden the types of studies available. Ref: http://www.medicalnewstoday.com/articles/264610.php
100% PROTECTION FOR MALARIA: EARLY CLINICAL STUDY SAYS… An early-stage clinical trial of an unusual experimental malaria vaccine shows it is safe, generates an immune response, and may provide 100% protection against malaria infection in healthy adults, the best result for a malaria vaccine so far. The trial tested the PfSPZ vaccine, developed by Sanaria Inc of Rockville, Maryland, in the US. The trial investigators included researchers from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health in the US, and other collaborators. According to the World Health Organization (WHO), over 200 million people worldwide became infected with malaria in 2010, and over 600,000 died of it, most of them young children in Africa where a child dies of malaria every minute. There is currently no vaccine for malaria, which is caused by five different strains of Plasmodium, a parasite that lives in the gut of the female Anopheles mosquito and passes to humans through her bite. The PfSPZ vaccine is unusual in that it does not use a handful of parasite proteins to provoke a immune response but live weakened forms of the whole, immature, "sporozoite" phase of the parasite. The challenge to produce the vaccine was huge. Mosquitoes had to be bred in sterile conditions on a massive scale, fed on parasite infected blood, and then irradiated to weaken the parasite - but not kill it - so it can infect people but not cause disease. Then billions of weakened parasites (in their imma-ture sporozoite phase) had to be harvested from the salivary glands of the irradiated mosquitoes, purified, and frozen. The PfSPZ vaccine has been tested in a phase I clinical trial, which took place at the NIAID Vaccine Research Center, in Bethesda, Maryland, and recruited 40 adult volunteers aged 20 to 44. The participants were given a range of intravenous vac-cine doses, and some (the controls) were not vaccinated at all. The effectiveness of the vaccine was then tested in the standard way for malaria vaccine testing. Three weeks after the final vaccination, both the vaccinated and non-vaccinated participants were exposed to bites by five mosquitoes carrying the P. falciparum strain, the same one the vaccine was made from. All six participants who received five doses re-mained free of malaria, while five of the six unvaccinated participants were infected, as were three of the nine who received only four doses of the vaccine. Ref: http://www.medicalnewstoday.com/articles/264610.php
www.auroushealthcare.com
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Universal Ethics Committee: Universal Ethics Committee: The Ethics Committee Division of The Ethics Committee Division of Aurous HealthCareAurous HealthCare——CRO…CRO…
Universal Ethics Committee (UEC), is a unit of Aurous HealthCare (CRO) that is regis-tered with CDSCO-DCGI holding registration number ECR/125/Indt/TN/2013 ECR/125/Indt/TN/2013 & OHRP (Office of Human Rights Protection, Unites States) - IRB00008683. UEC has been serving the Clinical Research fraternity since 2012 by providing guidance for conduct and ethi-cal clearance for clinical trial projects. Equipped with a GCP and Schedule Y compliant Expert member team, UEC contributes to the conduct of justified human (clinical) trials. We also review and ap-prove PMS studies... Contact : [email protected] or via +91Contact : [email protected] or via +91--98409091559840909155
AURO Days…AURO Days…
JANUARY:JANUARY:
31st : World Leprosy Day
FEBRUARY:FEBRUARY:
04th : World Cancer Day.
MARCHMARCH
08th : International Women’s day
12th : World Kidney
Day
22nd: World
Disability Day
24th : World TB Day
Check Your GCP Knowledge…Check Your GCP Knowledge…
1. What does ICH Stand for? A. International Convention on Homogenization B. International Convention on Harmonisation C. International Conference on Harmonisation 2. Name the person responsible for the conduct of the clinical trial at a trial site. A. Clinical Research Coordinator B. Investigator C. Clinical Research Associate/Monitor. 3. In which section of ICH- E6 (R1) are the essential documents listed? A. Section 6.2 B. Section 8 C. Section 5 D. Section 4.8.1 Answers on Page 7
RISK BASED MONITORING - OVERSIGHT OF CLINICAL INVESTIGATIONS… The United States - Food and Drug Administration (USFDA) brought our this Guideline for Industry “Oversight of Clinical Investigations - A Risk Bases Approach to Monitoring” in August 2013. This guideline is to assist sponsor or CRO in developing risk based monitoring strategies and plans for investigational studies of medical products, including human drug and biological products, medical devices and combinations thereof. The overall goal of this guidance is to enhance human subject protection and the quality of the clinical trial data by focusing sponsor oversight on the most important aspects of study conduct and data reporting. Effective monitoring of clinical trials by sponsors or CRO is critical to the protection of human subjects and the conduct of high quality studies. A risk based approach to monitoring focuses on sponsor oversight activities on preventing or mitigating important and likely risks to data quality and to processes critical to human subject protection and trial integrity. Monitoring findings should be evaluated to determine whether additional actions - training of Investigator and site staff, clarifications of protocol requirements) are necessary to ensure human subject protection and data quality across sites. The guideline gives an overview of the following monitoring methods
OnSite Monitoring: In person evaluation carried out by sponsor/CRO at the sites in which the clinical trial is being conducted Onsite monitoring helps identify data entry errors and missing data in source documents; assess familiarity of site staff with proto-col and required procedures and assess compliance.
Centralised Monitoring: Remote evaluation carried out by sponsor/CRO at locations other than clinical trial sites. Since this would heavily depend upon timely updation of electronic data capture modes, US-FDA ascertains that this will keep the timelines of the trial in a more realistic check. Every discrepancy and query resolution is monitored and tracked making it easier for cold audits and audit trails.
Risk Based Monitoring:
Identify critical data and processes to be monitored. Risk assessment - processes, policies and procedures.
Factors to consider when developing a monitoring plan * Complexity of study design * Study end points * Geography *Experience of Study team * Data Capture *Relative safety of the IP * Population and quantity of data captured.
The USFDA urges the comprehensive monitoring planning and execution to a CRO/personnel dedicated to the same, and effective communication with site and maintenance of communication documents.
Download the guideline : http://www.fda.gov/downloads/Drugs/.../Guidances/UCM269919.pdf
www.auroushealthcare.com
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AURO Quiz… AURO Quiz… Clinical ResearchClinical Research
1. Which is the document mandatory to enroll a subject
into a study?
A. Protocol B. Informed Consent Document
C. Voters ID D. All of the above
2. Who finances a Clinical Study?
A. Project Manager B. Sponsor
C. CRA D. Vendors
3. Identify this person who is generally credited as the
father of clinical research.
Clue: Oranges.
Next Edition: How well do you understand Next Edition: How well do you understand
Osteoporosis?? Osteoporosis?? Answers on Page 4
Check Your GCP Knowledge 1.C 2.B 3. B
Aurous HealthCareAurous HealthCare-- Pioneer in Clinical Studies on Herbaceuticals & Cosmeceuticals:Pioneer in Clinical Studies on Herbaceuticals & Cosmeceuticals:
Aurous HealthCare CRO is a pioneer is undertaking clinical studies for your Herbal Medicines and Cosmetics. Our specially designed clinical studies will…
Reinforce the Ayurvedic or Siddha potentially of your herbal medicine worldwide Help you with marketing your products internationally!!! Establish the safety of your cosmetics! We Help you identify consumer bliss points for your cosmetics!
Contact : [email protected] or at +91Contact : [email protected] or at +91--98409091559840909155
AUDIO-VIDEO RECORDING OF INFORMED CONSENT PROCESS MANDATORY - DCGI… With the official gazette notification in June 2013, CDSCO has mandated the audio-video recording of the informed consent process in all global clinical studies. This audio video recording was also to cover the procedure of providing information to the subject and his understanding on the subject. It is also mandated that the investigator provide information about the study verbally as well as using a patient information sheet, in a language that is non-technical and understandable by the study subject. The subject’s consent must be obtained in writing using an “Informed Consent Form” apart from the audio video recording of the entire procedure. Though the DCGI has made it imperative that all sponsors/CRO and other stakeholders involved in the conduct of the clinical trials, adhere to this effect immediately, there are many questions left unanswered by the office of CDSCO. Storage format of the AV recording. Confidentiality issues about storage of such an open evidence. Monitoring of the same by CRA. Duration of storage and policy for destruction. If the recording is to be performed for EVERY subject at a trial site.
Until such questions are answered , it does leave room to a lot of ambi-guity but this is a string initiative from CDSCO to ensure the safety of the subject.
EXERCISE IS JUST AS EFFECTIVE AS DRUGS : RESULTS OF CLINICAL STUDY… Scientists claim that exercise may be just as effective as drugs for treating common conditions, such as coronary heart disease and stroke. It has long been established that regular exercise is beneficial for health in general, but researchers now think exercise is "potentially as effective" as drug intervention, and they suggest it "should be considered as a viable alternative to, or alongside, drug therapy." Physical activity has well-documented health benefits, yet in England, roughly one-third of adults meet the recommended levels of physical activity. Physical activity has well documented health benefits. Population level cohort studies have shown that people who exercise enjoy a higher quality of life and improved health status compared with those with sedentary behaviours, with subsequent reductions in their risk of adverse outcomes such as admissions to hospital. Randomised controlled trials have shown similarly favourable findings in arthritis, cancer, diabetes, heart disease, and respiratory illnesses, among other chronic conditions. Large scale observational studies have also established a clear association between exercise and all cause mortality. Characteristics of exercise interventions The characteristics of the exercise interventions varied across treatment areas. Differences included the mode of physical activity and its frequency, intensity, and duration. Exercise based cardiac rehabilitation was typically a component of comprehensive cardiac care of patients with coronary heart disease. Patients with stroke received a mix of cardiorespiratory and muscle strengthening exercises. Physical activity was often a component of multifactorial lifestyle modification interventions to prevent diabetes among people with impaired glucose tolerance and impaired fasting glucose—that is, prediabetes Although limited in quantity, existing randomised trial evidence on exercise interventions suggests that exercise and many drug interventions are often potentially similar in terms of their mortality benefits in the secon-dary prevention of coronary heart disease, rehabilitation after stroke, treat-ment of heart failure, and prevention of diabetes. Ref: http://www.bmj.com/content/347/bmj.f5577
www.auroushealthcare.com
AUROUS HEALTHCARE RESEARCH AND DEVELOPMENT INDIA PRIVATE LIMITED
(Formerly Auroville HealthCare R & D India Pvt Ltd.)
#180/109, Rangarajapuram Main Road, Kodambakkam, Chennai-600024.
Phone: +91-44 23720600, +91-44 32472446 • Mobile: +91 9551050612 Fax: +91-4423720600
[email protected] [email protected] www.auroushealthcare.com
THE PIONEER THE PIONEER CONTRACT RESEARCH ORCONTRACT RESEARCH ORGANISATION (CRO) GANISATION (CRO) WITH FOCUS ON CLINICAL RESEARCHWITH FOCUS ON CLINICAL RESEARCH
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