aurouspeak - v01 ed 02 - the quarterly newsletter from the corporate of aurous healthcare cro

8/13/2019 AurouSpeak - V01 Ed 02 - The quarterly newsletter from the Corporate of Aurous HealthCare CRO

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Th e qua r ter ly n ewsletter from the Cor por a te of Aur ous Hea lthCar e - CRO.

Dec 2 13 Vol. 01 Ed. 02

Since 2008Since 2008

PROPRIETARY OF AUROUS HEALTHCARE R&D INDIA PRIVATE LIMITED

Aurous HealthCare R&D India Private Limited, 2008, All Rights Reserved

The pioneer Cont r act Resear ch Or gan isat ion ( CRO) wi th focus on Clinical Resear ch


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ht t p://aurousheal t hcare.wordpress.com/dr-v t -sri raam/

From the Desk of MDIt 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 clinicalresearch 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!

M y heart y w i shes for a heal t hy, happy and successful new year!!!

With Best Regards,

Dr. VT. Sriraam MBBS MD (Pharmacology)ManagingDirector |Medical directorAurous HealthCareCRO**************************************************************************************************************

Dr. VT. Sri raam M BBS MD (Pharmacology) is the founderdir ector of A urous Heal thCare- CRO.

An al umni of Stanl ey M edical College, he was honored as The Best Doctor by the Ministryof Healt h, M aldiv esat the age of 23.

Gaining rich and varied experience at top CRO, Dr. VT. Sriraam founded Aurous Healt hCarein 2008. An astute technocrat, his sharp business sense combined with his rich knowledge andexperience 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 CavinKaresChinnikr ishnan I nnovat ion Aw ard 2013.

A man w it h strengt hs so var ied and unique, Dr. VT.Sri raam i s the epit ome of t he

ent repreneuri al combinat i on of business brai ns and cl i ni cal- research creati ves.

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InsidensideAURO Ayur Page 4URO Ayur Page 4

Malarial Vaccine Trial Page 5alarial Vaccine Trial Page 5AURO BYTE Page 5URO BYTE Page 5

Risk based monitoring Page 6isk based monitoring Page 6AURO Days Page 6URO Days Page 6Exercise = Drugs Page 7xercise = Drugs Page 7

Aur ouSpeakin 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 !

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ETHICS COMMITTEEETHICS COMMITTEERE GISTRATION IN INDIARE GISTRATION 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 instreamlining 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 HealthCareAurous HealthCare are happy and proud to share

the information that our Universal Ethics CommitteeUniversal 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 8For details ...Page 8

www auroushealthcare com


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AURO AyurURO AyurChavya - Stem of Piper ni gr um

Sanskrit : Cavika

Assamese : Chepaan

Bengali : CheiEnglish : 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 ServicesClinical Trial Management Services

Aur ous Healt hCar eAurous Healt hCar eCRO:CRO:

AHC provides a complete package of comprehensive trial

management services for End t o End Cli ni cal Proj ects -

for New Chemical Entity, Chemical Entity, Herbal

Medicines, Nut r aceuti cals, Cosmeceut ical s - through

our Clinical Trial Project Management services inclusive

of contracts, budget management, logistics control and

coordination, Vendor management, Site Management

Servi ces for the successful completion of the project in-

cluding Clinical Study report. We also offer

exclu sive Sit e Management Serv ices.

Contact : mgr .bd@auroushealthcar e.comContact : mgr .bd@auroushealthcar e.com

or at +91or at +91--98409091559840909155

We also offer Cli ni cal Tr ia l Rescue Servi ces to help mend

strained SponsorCRO 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 acrossthe 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.

Thi s move fr om t he CDSCO is seen as t he fir st of t he

most important decisions in streamlining the

pr ocess and system of m edical r esearch in Ind ia.

This wil l pave way for ethical clini cal studi es and

safer tested products in the mar ket!

ETHICS C OMMITTEEETHICS C OMMITTEERE GISTRATION IN INDIAREGISTRATION IN INDIA

AuroQuizanswers:1.B2.B.3.JamesLind-ScurvyTrialww auroushealthcare com


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AURO ByteURO Byteht tp :/ / p rodom.prab i .f r / p rodom/ curr ent / h tml /ht tp :/ / p rodom.prab i .f r / p rodom/ curr ent / h tml /

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 OPPORTUNITI ES FOR THEIR

CHILDREN

To improve healthcare for children, medical research

that involves kids is a must. Yet, only five percent of parents saytheir 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 thatthey 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 SAYSAn 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 humansthrough 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 clinicaltrial, 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-

mai ned free of mala r ia, whil e five of the six unvaccinated

par ti cipant s were infected, as wer e thr ee of the nine who

r eceived onl y four doses of th e vaccin e.Ref: http://www.medicalnewstoday.com/articles/264610.php



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Universal Ethics Committee:Universal Ethics Committee: The Eth ics Comm it tee Divi sion ofThe Eth ics Comm it tee Divi sion of Aurous Healt hCar eAurous Healt hCar eCROCRO

Univer sal Eth ics Comm it tee (UEC), is a uni t of Aur ous Healt hCar e (CRO) that is regis-

tered with CDSCO-DCGI holdi ng r egistr at ion num ber ECR/ 125/ Indt/ TN/ 2013ECR/ 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 : uni ver salethi cscomm it [email protected] or via +91Contact : uni ver salethicscommi tt ee@gmai l.com or vi a +91--98409091559840909155

AURO DaysURO DaysJANUARY:JANUARY:

31st : World Leprosy Day

FEBRUARY:FEBRUARY:

04th : World Cancer Day.

MARCHMARCH

08th : International Womens day

12th : World Kidney

Day

22nd:World

Disability Day

24th : World TB Day

Check Your GCP Knowledgeheck Your GCP Knowledge1. 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 6.2B. 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 ClinicalInvestigat ions -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

OnSit e Monit ori ng: 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.

Centr ali sed Monit ori ng: 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 Monitor ing:

Ident if y cr it ical dat a and pr ocesses to be mon it or ed. Risk assessment - pr ocesses, poli cies and pr ocedur es.

Factor s to consider when developin g a monit ori ng 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 guidel ine : http:/ / ww w.fda.gov/down loads/ Drugs/.../ Guidances/UCM269919.pdf



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AURO QuizURO Quiz li n i ca l Resea rchli n i ca l Resea rch1. 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 w ell do you understandNext Edition: How w ell do you understand

Osteopor osis??Osteopor osis?? Answers on Page 4

CheckYourGCPKnowledge1.C2.B3.B

Aurous Healt hCar eAur ous Healt hCar e--Pioneer in Cli ni cal Studi es on Herbaceut ical s & Cosmeceuti cals:Pioneer in Cli ni cal Stud ies on Herbaceuti cals & Cosmeceuti cals:Aurous HealthCare CRO is a pioneer is undertaking clinical studies for

your Herbal Medicines and Cosmetics.

Our specially designed clinical studies willReinforce the Ayurvedic or Siddha potentially of your herbal medicine worldwideHelp you with marketing your products internationally!!!

Establish the safety of your cosmetics!We Help you identify consumer bliss points for your cosmetics!

Contact : mgr .bd@auroushealthcar e.com or at +91Contact : mgr .bd@auroushealthcar e.com 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 ofproviding 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 subjects 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 STUDYScientists 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 subsequentreductions 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 glucosethat

is, prediabetes

Although limited in quantity, existing randomised trial evidence on

exercise interventions suggests that exercise and many drug interventionsare 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



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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 PIONEERTHE PIONEER CONTRACT RESEARCH ORCONTRACT RESEARCH ORGANISATION (CRO)GANISATION (CRO) WITH FOCUS ON CLINICAL RESEARCHWITH FOCUS ON CLINICAL RESEARCH

www. auroushealthcare . wordpressauroushealthcare . wordpress .com The Quarterly Newsletter from AHCThe Quarterly Newsletter from AHC --CROCRO

Subscri be : Send an email toSubscrib e : Send an email to m gr .bd@au rou shealthcar e.comm gr .bd@au rousheal thcar e.com today...today...

aurouspeak - v01 ed 02 - the quarterly newsletter from the corporate of aurous healthcare cro

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