The quarterly newsletter from the Corporate of Aurous HealthCare...

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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 © Aurous HealthCare R&D India Private Limited, 2008, All Rights Reserved The pioneer Contract Research Organisation (CRO) with focus on Clinical Research

Transcript of The quarterly newsletter from the Corporate of Aurous HealthCare...

Page 1: The quarterly newsletter from the Corporate of Aurous HealthCare …auroushealthcare.com/pdf/AurouSpeak.pdf · The quarterly newsletter from the Corporate of Aurous HealthCare - CRO….

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

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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 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.

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 6AURO BYTE…………………………...Page 6

AURO Days………………..……..…..Page 6AURO Days………………..……..…..Page 6

A/ V of ICD Process A/ V of ICD Process -- DCGI…….Page 7DCGI…….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

ETHICS COMMITTEE REGISTRATION ETHICS COMMITTEE REGISTRATION IN INDIAIN 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 Commit-

tees 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 repre-

sentation along with resolution of conflict of interest; Application

Information - constitutive and administrative details of the EC.

Every functioning Ethics Committee in India was required

to submit an elaborate application to the office of DCGI, which in-

cluded information about constitution, composition of the commit-

tee inclusive of member appointment, terms of reference, replace-

ment and resignation procedures.

Elaborate details of the clinical trial proposals reviewed by

the committee thus far along with their Standard Operating Proce-

dures 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

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.

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 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

AuroQuiz answers: 1.B 2.B. 3. James Lind - Scurvy Trial www.auroushealthcare.com

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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 par-

ticipated 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 willing 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.

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 indi-

cated that they have never seen or heard about op-

portunities 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 child-

hood 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 avail-

able.

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 re-

sponse, and may provide 100% protection against malaria in-

fection 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 affected globally and over 600,000

died due to malaria in every minute in Africa.

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 immature

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, one the vaccine was made from.

All six participants who received five doses remained

free of malaria, while five of the six unvaccinated partici-

pants 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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#6

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

Answers on Page 7

www.auroushealthcare.com

AURO Byte… AURO Byte…

http://prodom.prabi.fr/prodom/current/html/home.phphttp://prodom.prabi.fr/prodom/current/html/home.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.

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 Next Edition: How well do you

understand Osteoporosis?? understand Osteoporosis?? Answers on Page 4

AURO Buzz… AURO Buzz… Orphan DiseaseOrphan Disease

CYSTIC FIBROSIS... Cystic fibrosis or CF is an inherited disease of the body's

mucus and sweat glands. It is a serious disease that affects

the respiratory and digestive systems in children and young

adults.

People with cystic fibrosis lose large amounts of salt when

they sweat.

Ref: www.nlm.nih.gov/medlineplus/tutorials/cysticfibrosis/id289105.pdf

Symptoms Frequent Wheezing, Pneumonia, Poor growth

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.

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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!

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 in-

formed consent process in all global clinical studies. This audio video recording was also to cover the procedure of pro-

viding 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.

Until such questions are answered , it does leave room to a lot of ambiguity 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 re-

searchers now think exercise is "potentially as effective" as drug intervention, and they suggest “it should be consid-

ered as a viable alternative to, or alongside, drug therapy."

Population level cohort studies have shown that people who exercise enjoy a higher quality of life and im-

proved health status compared with those with sedentary behaviours, with subsequent reductions in their risk of ad-

verse 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.

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 compo-

nent of comprehensive cardiac care of patients with coronary heart disease. Patients with stroke received a mix of car-

diorespiratory 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 inter-

ventions suggests that exercise and many drug interventions are often potentially similar

in terms of their mortality benefits in the secondary prevention of coronary heart dis-

ease, rehabilitation after stroke, treatment of heart failure, and prevention of diabetes.

Ref: http://www.bmj.com/content/347/bmj.f5577

www.auroushealthcare.com

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.

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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 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

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