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The quarterly newsletter from the Corporate of Aurous HealthCare - CRO….
Mar 2014 Vol. 01 Ed. 03
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……...
As a business man, I am aware that the dawn of another financial year looms close. But the medical
entrepreneur in me , is excited like a child on his birthday.
Our AURO-BLOG has been religiously capturing the pulse of the Drug Research Industry and it
thrills me to see the progress we are making towards a more regulated and scientifically advanced world.
The happiness also stems from the very promising activity in the sphere of AYUSH!
The world is travelling back to its ancient roots and the foray of herbal cosmetics with natural
extracts and ingredients, is the most fascinating progress of recent times. AYURVEDA and SIDDHA is
making it’s presence felt with safer, milder herbal medicines and cosmetics. It prides me that the most an-
cient science of our land is being reinvented to match the standards of modern science and provide the saf-
est and most suitable care to our health.
It is interesting to note that Clinical Studies are no longer feared upon as an experimentation but
are being considered as the medically apt scientific approach to ensuring the safety and efficacy of
your product - even an AYURVEDIC or SIDDHA formulation that has been around for years -
before it reaches the larger public.
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 medical entreprenuer, 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.
AurouSpeak
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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
AurouSpeak
in your INBOX !!!
Send a test mail and receive quarterly updates
on Clinical Trials and Drug Research in your
inbox!
[email protected] [email protected]
Register!Register!
AurouSpeak
#3 www.auroushealthcare.com
AurouSpeak
#4
AURO Ayur…AURO Ayur…
Madana...
Scientific name: dried
fruit of Xeromphis spinosa
Sanskrit : Madani
Assamese : Maen
Bengali : Mayanaphal
English : Emetic nut
Gujrati : Mindhol
Hindi : Manphal
Kannada : Mangarikkai, Karigidda
Malayalam : Malankara; Marathi : Ghalphala
Tamil : Marukarrai; Telugu : Monga Kaya; Urdu : Mainphal
Medicinal uses:
Main use is that as an emetic agent.
In smaller doses it is a nauseant, expectorant and diaphoretic.
In smaller doses for the teething problems of infants.
Also credited with antihelminthic properties.
Applied externally for rheumatic pain.
Ayurvedic Properties and Action:.
Rasa: Madura, Tikta
Guna: Laghu, Rukha.
Virya: Usna
Vipaka: Katu
Karma: Vamana, Lekhana
Dose: 1-2g of the drug in powder form. Ref : The Ayurvedic Pharmacopeia of India - Part I - Volume II
Contact : Contact : [email protected] [email protected] +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 audit services.
AuroQuiz answers: 1.B 2.B. 3A. 4A. 5A. www.auroushealthcare.com
AurouSpeak
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AURO Byte… AURO Byte…
BLAST: Basic Local Alignment Search ToolBLAST: Basic Local Alignment Search Tool
www.ncbi.nlm.nih.gov/BLAST/
The Basic Local Alignment Search Tool (BLAST) finds regions of local similarity between
sequences. The program compares nucleotide or protein sequences to sequence databases and
calculates the statistical significance of matches. BLAST can be used to infer functional and
evolutionary relationships between sequences as well as help identify members of gene
families. A BLAST search enables a researcher to compare a query sequence with a library or database of sequences, and identify library
sequences that resemble the query sequence above a certain threshold. The BLAST program was designed by Stephen Altschul,
Warren Gish, Webb Miller, Eugene Myers, and David J. Lipman at the National Institute of Health in 1990.
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
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…
APRIL:APRIL:
7 : World Health Day
17 : World Hemophilia Day
25 : World Malaria Day
MAY:MAY:
6 : World Asthma Day.
8 : World Red Cross Day.
12 : International Nurses Day.
17 : World Hypertension Day
JUNEJUNE
14 : World Blood
Donation Day
Check Your GCP Knowledge…Check Your GCP Knowledge…
1. What are the absolute minimum requirements for essential documents at site before Investigational Product can be sent to clinical trial site? A. Clinical Trial Agreement & CV of Investigator B. Clinical Trial Agreement & Ethics Committee Approval C. Clinical Trial Agreement & Singed Protocol. 2. According to ICH GCP when should a sponsor provide an audit certificate? A. Always B. When audit is successful. C. When required by law or regulation. 3. ICH GCP states that a Sponsor Audit is independent and separate from which of the following? A. Routine Monitoring & Regulatory Audit. B. Site Close out Visit C. Investigator’s Meeting.
www.auroushealthcare.com
AurouSpeak
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AURO Quiz… AURO Quiz… Osteoporosis . . .Osteoporosis . . .
1. What is the other common name for osteoporosis?
A. Bone Disease B. Silent Disease
C. Silent Death D. Bone Death
2. What is the most common fracture observed with
osteoporosis?
A. Vertebrae B. Hip
C. Leg D. Hand
3. What is the stage of disease before Osteoporosis
called?
A. Osteopenia B. OsteoFracture
C. Osteodepletion D. OsteoCalcium Loss
4. What is the gold standard test for Osteoporosis?
A. BMD-DEXA scan B. Bone Xray
C. Treadmil Test D. Fracture test
5. What is the daily requirement of Calcium in mg/day
for an adult?
A. 1200mg B. 2000mg
C. 3000mg D. 3200mg
Next Edition: Next Edition: How well do you know AYURVEDA??How well do you know AYURVEDA?? Answers on Page 4
Check Your GCP Knowledge 1.B 2.C 3. A
Aurous HealthCareAurous HealthCare-- Pioneer in Clinical Studies on Pioneer in Clinical Studies on HerbaceuticalsHerbaceuticals & & Cosmeceuticals:Cosmeceuticals:
①① Cost Effective Research!Cost Effective Research!
② Customised Clinical Trial Design!② Customised Clinical Trial Design!
③ ③ World Health Organisation World Health Organisation
&& ICMR Listing for YOUR company!ICMR Listing for YOUR company!
④ Specialised Medical Writing!④ Specialised Medical Writing!
⑤ Internationally Accepted Reports!⑤ Internationally Accepted Reports!
⑥ End to End Study & Regulatory Aid!⑥ End to End Study & Regulatory Aid!
Contact : [email protected] or +91Contact : [email protected] or +91--98409091559840909155
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
www. auroushealthcare . wordpress auroushealthcare . wordpress .com The Quarterly Newsletter from AHC The Quarterly Newsletter from AHC -- CROCRO
Subscribe : Send an email to Subscribe : Send an email to [email protected] [email protected] today...today...