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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
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 alumnus 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.
AHC provides a complete package of comprehensive trial
management services for End to End Clinical Projects -
for New Chemical Entity, Chemical Entity, Herbal Medi-
cines, Nutraceuticals, Cosmeceuticals - through our
Clinical Trial Project Management services inclusive of con-
tracts, budget management, logistics control and coordi-
nation, Vendor management, Site Management Services
for the successful completion of the project including Clini-
cal Study report. We also offer exclusive Site Manage-
ment 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
ETHICS COMMITTEE REGISTRATION ETHICS COMMITTEE REGISTRATION IN INDIAIN INDIA
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 registered 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 ethical 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 approve 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
Diagnosis Sweat tests, X - rays, Lung function test
Treatment At present, there is no cure for cystic fibrosis.
Prevention Preventing CF is not possible once a baby is born.
AurouSpeak
#7 Check Your GCP Knowledge 1.C 2.B 3. B
Aurous HealthCareAurous HealthCare--Pioneer CRO in Clinical Studies on Herbaceuticals & Cosmeceuticals:Pioneer CRO in Clinical Studies on Herbaceuticals & Cosmeceuticals:
Aurous HealthCare is a pioneer CRO, 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!
THE PIONEER THE PIONEER CONTRACT RESEARCH ORCONTRACT RESEARCH ORGANISATION (CRO) GANISATION (CRO) WITH FOCUS ON CLINICAL RESEARCHWITH FOCUS ON CLINICAL RESEARCH
www. auroushealthcare . wordpress auroushealthcare . wordpress .com The Quarterly Newsletter from AHC The Quarterly Newsletter from AHC -- CROCRO