The Quarterly Newsletter from the Corporate of Aurous ... · multicentre, double blinded Phase III...

Dec 2016 Dec 2016 Anniversary EditionAnniversary EditionAnniversary Edition Vol.04 Ed.02Vol.04 Ed.02

The Quarterly Newsletter from the Corporate of Aurous HealthCare The Quarterly Newsletter from the Corporate of Aurous HealthCare The Quarterly Newsletter from the Corporate of Aurous HealthCare --- CRO…CRO…CRO…

http://auroushealthcare.wordpress.com/drhttp://auroushealthcare.wordpress.com/dr--vtvt--sriraam/ sriraam/

From the Desk of From the Desk of AHCAHC--iansians…… Dear MD Sir, Dear MD Sir,

Every AurouSpeak, you write to everyone. This time, we thought we could write to you.Every AurouSpeak, you write to everyone. This time, we thought we could write to you.

We speak for every employee ever associated with Aurous CRO when we say that its We speak for every employee ever associated with Aurous CRO when we say that its

been an absolute honor and privilege to have learnt clinical research under your able been an absolute honor and privilege to have learnt clinical research under your able

tutelage.tutelage.

From raw clay to misshapen learnings, you have taught with earnest enthusiasm and From raw clay to misshapen learnings, you have taught with earnest enthusiasm and

shaped us to be the individuals that we are today.shaped us to be the individuals that we are today.

At Aurous CRO, we have had the opportunity to work with varied aspects of research At Aurous CRO, we have had the opportunity to work with varied aspects of research

from in vitro, animal studies, medical writing to clinical studies.from in vitro, animal studies, medical writing to clinical studies.

The amount of experience that comes from a clinical trial that is completely conceived, The amount of experience that comes from a clinical trial that is completely conceived,

designed, conducted, analysed and reported by Aurous CRO, can only be understood designed, conducted, analysed and reported by Aurous CRO, can only be understood

by being part of the R&D team.by being part of the R&D team.

Several times we have tired over the huge number of forms and processes to be followed Several times we have tired over the huge number of forms and processes to be followed

for each project. But the meticulous flow of activities in the system designed by you is for each project. But the meticulous flow of activities in the system designed by you is

realized only during peerrealized only during peer--discussions of industry standards.discussions of industry standards.

For every mistake, for every error, for every incident that you took the fall for us, for For every mistake, for every error, for every incident that you took the fall for us, for

every time you gave us the spotlight, we are thankful!every time you gave us the spotlight, we are thankful!

Very few footsteps that have walked through Aurous CRO will fully realize your truest Very few footsteps that have walked through Aurous CRO will fully realize your truest

abilities, your magnanimity and the mammoth potentiality ofAurous CRO. But each abilities, your magnanimity and the mammoth potentiality ofAurous CRO. But each

of us have felt it.of us have felt it.

Sir, We thank you and Wish the very best of all happiness, health, success Sir, We thank you and Wish the very best of all happiness, health, success

and fortune for you and Aurous CRO, this New Year!!!and fortune for you and Aurous CRO, this New Year!!!

Thank you Sir!Thank you Sir!

Regards,Regards,

AHCAHC--ians.ians.

D r . V T . S r i r a a m M B B S M D D r . V T . S r i r a a m M B B S M D

(Pharmacology) is the founder(Pharmacology) is the founder –– director director

of Aurous HealthCare of Aurous HealthCare -- CRO.CRO.

An alumni of Stanley Medical College, he was An alumni of Stanley Medical College, he was

honored as “The Best Doctor” by the Ministry of honored as “The Best Doctor” by the Ministry of

Health, Maldives at the age of 23. Health, Maldives at the age of 23.

Gaining rich and varied experience at top CRO, Gaining rich and varied experience at top CRO,

Dr. VT. Sriraam founded Aurous HealthCare in Dr. VT. Sriraam founded Aurous HealthCare in

2008. An astute medical entrepreneur, his sharp 2008. An astute medical entrepreneur, his sharp

business sense combined with his rich knowledge business sense combined with his rich knowledge

and experience in the field of clinical research and experience in the field of clinical research

has pushed Aurous HealthCare from strength to has pushed Aurous HealthCare from strength to

strength. strength.

Dr.Sriraam has been recognized with Dr.Sriraam has been recognized with

NATIONAL AWARD NATIONAL AWARD -- “Indian Leadership “Indian Leadership

Award for Healthcare Excellence”, Award for Healthcare Excellence”, for for

his contributions in the field of medical his contributions in the field of medical

researchresearch

A man with strengths so varied and unique, A man with strengths so varied and unique,

Dr.VT.Sriraam is the epitome of the Dr.VT.Sriraam is the epitome of the

entrepreneurial combination of business brains entrepreneurial combination of business brains

and clinicaland clinical--research creatives.research creatives.

AurouSpeakAurouSpeak

#2#2

Inside…Inside… Snippets from Snippets from AuroBlogAuroBlog....................Page 5....................Page 5

AURO QuizAURO Quiz.......................................Page 6.......................................Page 6

Biosimilar GuidelineBiosimilar Guideline ...........................Page 6...........................Page 6

AURO AURO SiddhaSiddha...................................Page 6...................................Page 6

Universal Ethics CommUniversal Ethics Comm ittee...............Page 6ittee...............Page 6

AurouSAurouSpeakpeak in your INBOX !!!in your INBOX !!!

Send a test mail and receive quarterly updates Send a test mail and receive quarterly updates on Clinical Trials and Drug Research in your on Clinical Trials and Drug Research in your inbox!inbox!

[email protected]@outlook.com


#3#3 www.auroushealthcare.comwww.auroushealthcare.com

One Year with CDSCO Online!One Year with CDSCO Online!

Does the SUGAM work?Does the SUGAM work?

CDSCO’S ONLINE SUGAM PORTAL...CDSCO’S ONLINE SUGAM PORTAL... An online licensing portal of CDSCO (Central Drug Standard Control

Organisation) has been implemented from January 2016. It has been

named “SUGAM” to file applications for various services like

Application Submission, processing and grant of permission for quick

delivery of services,

SUGAM Online Services

Online Submission

Review

Grant of NOC/Permission

Benefits in SUGAM Online Portal

The registration document review, submission and tracking has

become simpler, efficient and transparent

Helps in keeping track of all past and current regulatory

applications including the facility to keep applications as draft

Upon submission, the status bar shows the number of days left for

CDSCO to answer

A new Notification section allows you to easily access

notifications and responses from the past week.

Queries raised are also sent as SMS alerts!!

Sugam Challenges

No provision to upload files greater than 10 MB

Documents are split into multiple sections instead of one single

report.

No provision to upload multiple files in the same section.

Mandatory to upload all sections. Sections that are not

applicable are being filled by companies using a one page docu-

ment that says “not applicable”

Online payment not clear. Several banks not listed.

No provision to download the form once submitted. Only preview is available.

Source: Morulaa HealthTEch

Note: There is no issue of AurouSpeak marked Volume 04 Edition 01 dated Sep 2016Note: There is no issue of AurouSpeak marked Volume 04 Edition 01 dated Sep 2016


#4#4 AuroQuiz answers: 1A. 2C. 3B. 4A. 5B.

www.auroushealthcare.comwww.auroushealthcare.com



THE LASTEST IN THE WTHE LASTEST IN THE WORLD OF CLINICAL RESEARCH & THE PHARMA INDUSTRY…ORLD OF CLINICAL RESEARCH & THE PHARMA INDUSTRY…

* SNIPPETS FROM AUROBLOG ** SNIPPETS FROM AUROBLOG *

EBOLA VACCINE 100% EEBOLA VACCINE 100% EFFECTIVE IN CLINICALFFECTIVE IN CLINICAL TRIAL...TRIAL... rVSV-ZEBOV Clinical Trial on Ebola virus vaccine was 100% effective in preventing the disease after 10 days in the

5837 people who received it in Guinea and Sierra Leone. Meanwhile, 23 of the 4507 people who did not receive the vaccine

contracted the virus in the same timeframe.

AALZHEIMER’S DRUG HITSLZHEIMER’S DRUG HITS MAJOR MILESTONE IN MAJOR MILESTONE IN CLINICAL TRIAL…CLINICAL TRIAL… Verbecestat - Drug by Merck as shown promise in clinical trial involving over 3500 patients. It targets the toxic amyloid

proteins in the brain and could be the first treatment to enter the market in more than 10 years!

ZIKA VIRUS ENTERS PHZIKA VIRUS ENTERS PHASE I CLINICAL TRIALS ...ASE I CLINICAL TRIALS ... As the first local mosquito-borne transmissions of the Zika virus are being reported in the continental United States, an

investigational vaccine developed by the National Institute of Allergy and Infectious Diseases (NIAID) at the National

Institutes of Health (NIH) is entering phase 1 clinical trials.

USFDA APPROVES PFIZEUSFDA APPROVES PFIZER’S DRUG FOR BREAST CANCER...R’S DRUG FOR BREAST CANCER... Monoclonal antibody IBRANCE (palbociclib) has been approved by the USFDA based on PALOMA-2 - the randomized,

multicentre, double blinded Phase III study conducted by Pfizer in over 600 women in 186 global sites in 17 countries. This

drug is to work as a first line treatment for post menopausal women with ER+, HER2- metastatic breast cancer

ONLINE PHARMACY IN TONLINE PHARMACY IN TAMIL NADU SOON...AMIL NADU SOON... Tamil Nadu Pharmacist Awareness Organisation (TN PAO) which will control the network business in Tamil Nadu.

TN PAO has 800 registered pharmacists who will help the retail pharmacies in delivering the medicines to the online con-

sumers”

AYUSH MINISTRY TO AMAYUSH MINISTRY TO AMEND D&C RULES TO PROHIT MISLEADING ADS..END D&C RULES TO PROHIT MISLEADING ADS.... The ministry is now amending the law as it is aware of the sale and advertisement of ayurvedic medicines through TV

channels which are required to adhere to the Advertising Code prescribed under the Cable TV Networks (Regulation) Act,

1995 and Rules framed thereunder.

HEALTH MINISTRY ISSUHEALTH MINISTRY ISSUES REVISED ELECTRONIC HEALTH RECORD STANDARDS...ES REVISED ELECTRONIC HEALTH RECORD STANDARDS... Union health ministry has issued the revised Electronic Health Record (EHR) standards-2016 which is a continuation of its

earlier version. In many ways they reflect the growing confidence in the path correctly chosen earlier – providing a set of

international and proven standards with focus towards achieving syntactic and semantic interoperability of health records

Subscribe : Send an email to Subscribe : Send an email to [email protected]@outlook.com today...today...



AURO Quiz…AURO Quiz…Clinical Research...Clinical Research...

1. Name the Clinical Trial Design when you say Drug A

is better than Drug B ?

a. Superiority Trial b. Inferiority Trial

c. Non-Inferiority Trial d. Best Drug Trial

2. Name the Clinical Trial Design when you say Drug A

is as good as Drug B ?

a. Superiority Trial b. Inferiority Trial

c. Non-Inferiority Trial d. Best Drug Trial

3. Name the Clinical Trial Design when the names of

the drugs are masked from the Doctor & Subject?

a. Open Label b. Double Blinded

c. Prospective Label d. Control Label

4. What is the technical term for “Dummy Drug”

a. Placebo b. Nocebo

c. Adverse Event d. SUSAR

5. What is the technical term for ill effects from a

Dummy Drug?

a. Placebo b. Nocebo

c. Adverse Event d. SUSAR

Next Edition: How well do you understand Next Edition: How well do you understand Ayurveda Clinical Trials.Ayurveda Clinical Trials. Answers on Page 4

AMENDED BIOSIMILARS AMENDED BIOSIMILARS GUIDELINE IN INDIA..GUIDELINE IN INDIA....

Biosimilar: A Biological medical product that has similar

structural and functional properties to a product that has already

been licensed and marketed.

The CDSCO has amended the biosimilars guideline of 2012 making

certain major changes.

Changes include that the reference biological material is accepted

even if not marketed in India as long as its been licensed in any of

the ICH countries.

The major amendment however comes in the section of Post

Marketing Surveillance Studies.

PMS Studies are expected within 2 years of marketing permission or

manufacturing license unless otherwise justified.

Key Parameters of Biosimilars PMS Studies

* Primary End Point : Safety

* Secondary End Point : Efficacy and Immunogenicity

Pre-approval studies must include more than 100 patients on the

proposed biosimilar. The Phase IV study may have less if Phase III

data has been obtained on a minimum of 300 patients.

In addition to the revision of some of the earlier guidelines, the EMA

published guidelines for pharmacovigilance of biologics in 2016.

The US FDA has published a guidance on the labelling of biosimilars

in March 2016.

The naming of biologicals and interchangability of biosimilars

continue to be hotly debated topics. The EMA has approved biosimi-

lars under the same non-proprietary name as for the reference

product. In 2015, the US FDA issued draft guidance on the subject of

non-proprietary naming of biosimilars. This guidance recommends

that all biologicals should have non-proprietary names that in-

cludes a four-letter suffix to distinguish them from each other. The

suffix would be composed of four lowercase letters and not carry

any meaning.

The proposed approach is intended with a view to clearly

identifying biological products to improve pharmacovigilance, and,

preventing any unintended substitution. However, a number of in-

dustry stakeholders, including the USP have requested for

alternative approaches to be considered.

AURO AURO Siddha Siddha -- FruitsFruits……

Pineapple... Siddha Action: Styptic, Emmenagogue, Anthelmintic,

Vermicide, Diaphoretic,

Siddha Action: Useful in vomiting, gastralgia,

jaundice, excessive thirst and other

pitha diseases.

Lemon… Siddha Action: Pithasamani, antiscorbutic Siddha Action: Curing giddiness, vomiting, nausea,

thirst, scurvy, dysentery.

Guava... Siddha Action: Laxative

Siddha Action: dyspepsia, anorexia. Unripe fruit for

diarrhea and gout.

Custard Apple... Siddha Action: Tonic, Haematinic

Siddha Action: reduces body heat. Ripe fruit is

mashed and applied to hasten suppuration.

Papaya... Siddha Action: Laxative, Digestive, Diuretic,

Anthelmintic

Siddha Action: Intestinal irritayions and gastralgia.

Unripe fruit+honey is used to treat round worms.



Universal Ethics Committee: Universal Ethics Committee: The Ethics Committee Division of The Ethics Committee Division of Aurous HealthCare Aurous 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 Post Marketing Surveillance studies...We also review and approve Post Marketing Surveillance studies...

Contact : [email protected]; [email protected]; or via +91Contact : [email protected]; [email protected]; or via +91--98409091559840909155

AUROUS HEALTHCARE RESEARCH AND DEVELOPMENT INDIA PRIVATE LIMITED

(Formerly Auroville HealthCare R & D India Pvt Ltd.)

#180/109, G1&G2, RR Villa, Rangarajapuram Main Road, Kodambakkam, Chennai-600024.

Phone: +91-44 23720600, +91-44 32472446 • Mobile: +91 9840909155 Fax: +91-4423720600

[email protected] [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]@outlook.com today...today...

The Quarterly Newsletter from the Corporate of Aurous ... · multicentre, double blinded Phase III...

Documents

Transcript of The Quarterly Newsletter from the Corporate of Aurous ... · multicentre, double blinded Phase III...