We believe - rellife.com · 19cms X 28cms Leaflet 02 Front Laboratory Animal Research Services The...

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Transcript of We believe - rellife.com · 19cms X 28cms Leaflet 02 Front Laboratory Animal Research Services The...

Page 1: We believe - rellife.com · 19cms X 28cms Leaflet 02 Front Laboratory Animal Research Services The Laboratory Animal Research Services (LARS) group provides in-vivo efficacy and pre-clinical
Page 2: We believe - rellife.com · 19cms X 28cms Leaflet 02 Front Laboratory Animal Research Services The Laboratory Animal Research Services (LARS) group provides in-vivo efficacy and pre-clinical

We believe... …trust is earned

Audits and Certifications

Reliance places utmost emphasis on quality management of its

facilities and processes .

We are audited by:

nVendor Audits

lBy top five Indian generic pharmaceutical companies

lBy international pharmaceutical and biotechnology

companies

nRegulatory Audits for BA/BE facilities

lTwo US FDA inspections completed and BE results

approved for ANDA

lTurkey MoH - Approved

lIsrael MoH – Approved

lANVISA (Brazil) - Approved

lMPA (Sweden) - Approved

lDCG(I) / CDSCO – Approved

nInternal Audits

lProspective and Retrospective

lClinical QA

lAnalytical / Pathological QA

nInternal Independent Auditors

nExternal Independent Auditors and Consultants including

Association for the Accreditation of Human Research

Protection Programs (in progress)

The Reliance Experience

One stop shop offering value through

integrated clinical research services.

nBioavailability / Bioequivalence

clinical studies and Phase-I human clinical trials:

Projects Completed: 110

Pivotal studies USFDA: 23

MHRA, UK/EMEA, Europe/ MPA, Sweden: 11

AFSSAPS, France: 1

MCC, South Africa: 3

ASEAN, Indonesia: 2

Soviet Union/ Russia: 3

ANVISA, Brazil: 2

Turkey MoH: 5

DCGI: 5

nPhase II-IV clinical trials:

Total number of studies/projects: 80

Projects Completed: 48

Ongoing Projects: 32

Geographical location of sites managed by Reliance:

India and Eastern Europe.

Regulatory authorities to whom data is submitted:

USFDA/ MCA/ DCG(India)/ SE Asia/ Local European MoH

Leaflet 01 Front Leaflet 01 Back19cms X 28cms

Our experience includes:

n

line therapy in NSCLC, Recombinant agent in Renal Cell

Carcinoma, Recombinant agent as monotherapy in

NSCLC, Relapsed Refractory Multiple Myeloma,

Radiomodifier in Glioblastomas, Cachexia in cancer

patients, PDT in Hepatocellular Carcinoma, Cachexia in

Refractory NSCLC, Metastatic Breast cancer, Head and

Neck Cancer.

nInfectious Diseases: Methicillin Resistant Staphylococcus

Aureus infections, Aspergillosis, Severe Sepsis, Chronic

Bronchitis

nVaccines: Early clinical phase HIV Vaccine Development,

Early clinical phase Tuberculosis, Phase-III Rotavirus

vaccine trial, Phase-I Anthrax vaccine trial, Pediatric

Vaccine: Hepatitis B and DTP

nPsychiatry: Major Depressive Disorder, Adolescent

Schizophrenia, Severe Depression

nGynaecology: Sterilization by Chemical Method

Oncology: Chemo with concurrent biological agent as first n

Dwarfism,Hyperparathyroidism

nDermatology: Plain and Interactive wound covers, Deep

Seated wound covers, Dose Ranging Enzymatic Therapy

for debridement in burn wounds, stable vitiligo.

nHaematology/Thrombosis: Chemotherapy induced

neutropenia, Anemia in Cervical Cancer, Anti thrombosis.

nGastroenterology: Chronic Hepatitis B, Traveller's

Diarrhoea, Crohn's Disease

nOrthopaedics: NSAIDs in Osteoarthritis, Herbal formulation

in Osteoarthritis

nOphthalmology: Corneal disorders, Conjunctival disorders,

Chronic blepharitis

nNephrology: Probiotic in Chronic Renal disease, End Stage

Renal Disease

nNeurology: Epilepsy, Cervical Dystonia

nCardiovascular: Cholesterol lowering agents, Myocardial

Infarction, Risk of Cardiovascular disease, Angina

Endocrinology: Oral anti-diabetics, Diabetic Foot Ulcers,

nData Management:

Projects Completed: 10 Ongoing Projects: 16

nBiostatistics:

Projects Completed: 10 Ongoing Projects: 12

nReport Writing:

Projects Completed: 8 Ongoing Projects: 14

Reliance Life Sciences Pvt. Ltd.

Dhirubhai Ambani Life Sciences Centre, Thane-Belapur Road,

Rabale, Navi Mumbai - 400 701, INDIA.

Tel: (IND)+91 22 6767 8000 • Fax: +91 22 6767 8299

Tel: (UK)+44 7920420911, +44 7717177123

Email: [email protected]

Website: www.relclin.com

Page 3: We believe - rellife.com · 19cms X 28cms Leaflet 02 Front Laboratory Animal Research Services The Laboratory Animal Research Services (LARS) group provides in-vivo efficacy and pre-clinical

We believe... …trust is earned

Audits and Certifications

Reliance places utmost emphasis on quality management of its

facilities and processes .

We are audited by:

nVendor Audits

lBy top five Indian generic pharmaceutical companies

lBy international pharmaceutical and biotechnology

companies

nRegulatory Audits for BA/BE facilities

lTwo US FDA inspections completed and BE results

approved for ANDA

lTurkey MoH - Approved

lIsrael MoH – Approved

lANVISA (Brazil) - Approved

lMPA (Sweden) - Approved

lDCG(I) / CDSCO – Approved

nInternal Audits

lProspective and Retrospective

lClinical QA

lAnalytical / Pathological QA

nInternal Independent Auditors

nExternal Independent Auditors and Consultants including

Association for the Accreditation of Human Research

Protection Programs (in progress)

The Reliance Experience

One stop shop offering value through

integrated clinical research services.

nBioavailability / Bioequivalence

clinical studies and Phase-I human clinical trials:

Projects Completed: 110

Pivotal studies USFDA: 23

MHRA, UK/EMEA, Europe/ MPA, Sweden: 11

AFSSAPS, France: 1

MCC, South Africa: 3

ASEAN, Indonesia: 2

Soviet Union/ Russia: 3

ANVISA, Brazil: 2

Turkey MoH: 5

DCGI: 5

nPhase II-IV clinical trials:

Total number of studies/projects: 80

Projects Completed: 48

Ongoing Projects: 32

Geographical location of sites managed by Reliance:

India and Eastern Europe.

Regulatory authorities to whom data is submitted:

USFDA/ MCA/ DCG(India)/ SE Asia/ Local European MoH

Leaflet 01 Front Leaflet 01 Back19cms X 28cms

Our experience includes:

n

line therapy in NSCLC, Recombinant agent in Renal Cell

Carcinoma, Recombinant agent as monotherapy in

NSCLC, Relapsed Refractory Multiple Myeloma,

Radiomodifier in Glioblastomas, Cachexia in cancer

patients, PDT in Hepatocellular Carcinoma, Cachexia in

Refractory NSCLC, Metastatic Breast cancer, Head and

Neck Cancer.

nInfectious Diseases: Methicillin Resistant Staphylococcus

Aureus infections, Aspergillosis, Severe Sepsis, Chronic

Bronchitis

nVaccines: Early clinical phase HIV Vaccine Development,

Early clinical phase Tuberculosis, Phase-III Rotavirus

vaccine trial, Phase-I Anthrax vaccine trial, Pediatric

Vaccine: Hepatitis B and DTP

nPsychiatry: Major Depressive Disorder, Adolescent

Schizophrenia, Severe Depression

nGynaecology: Sterilization by Chemical Method

Oncology: Chemo with concurrent biological agent as first n

Dwarfism,Hyperparathyroidism

nDermatology: Plain and Interactive wound covers, Deep

Seated wound covers, Dose Ranging Enzymatic Therapy

for debridement in burn wounds, stable vitiligo.

nHaematology/Thrombosis: Chemotherapy induced

neutropenia, Anemia in Cervical Cancer, Anti thrombosis.

nGastroenterology: Chronic Hepatitis B, Traveller's

Diarrhoea, Crohn's Disease

nOrthopaedics: NSAIDs in Osteoarthritis, Herbal formulation

in Osteoarthritis

nOphthalmology: Corneal disorders, Conjunctival disorders,

Chronic blepharitis

nNephrology: Probiotic in Chronic Renal disease, End Stage

Renal Disease

nNeurology: Epilepsy, Cervical Dystonia

nCardiovascular: Cholesterol lowering agents, Myocardial

Infarction, Risk of Cardiovascular disease, Angina

Endocrinology: Oral anti-diabetics, Diabetic Foot Ulcers,

nData Management:

Projects Completed: 10 Ongoing Projects: 16

nBiostatistics:

Projects Completed: 10 Ongoing Projects: 12

nReport Writing:

Projects Completed: 8 Ongoing Projects: 14

Reliance Life Sciences Pvt. Ltd.

Dhirubhai Ambani Life Sciences Centre, Thane-Belapur Road,

Rabale, Navi Mumbai - 400 701, INDIA.

Tel: (IND)+91 22 6767 8000 • Fax: +91 22 6767 8299

Tel: (UK)+44 7920420911, +44 7717177123

Email: [email protected]

Website: www.relclin.com

Page 4: We believe - rellife.com · 19cms X 28cms Leaflet 02 Front Laboratory Animal Research Services The Laboratory Animal Research Services (LARS) group provides in-vivo efficacy and pre-clinical

Leaflet 02 Front19cms X 28cms

Laboratory Animal Research Services

The Laboratory Animal Research Services (LARS) group provides in-vivo efficacy and pre-clinical safety studies for cell-based

therapies, proteins and chemical entities.

The LARS is a OECD- GLP certified Toxicology facility. It also has

Indian GLP certification. The animal facility is registered with the

Committee for the Purpose of Control and Supervision of

Experiments on Animals (CPCSEA) and conforms to its

guidelines.

LARS value proposition includes

nState-of-the-art, barrier maintained facility with robust

environmental monitoring system

nStudies in compliance with OECD principles of GLP

nConduct of chronic studies in Specific Pathogen

Free animals

nFully automated clinical and histopathology laboratory with

highly skilled pathologists and technicians

nHighly qualified professionals experienced in GLP certified

labs to conduct toxicity studies

nIndependent QA team to conduct study, process and

facility based inspections

The experience and capabilities include:

nRegulatory Toxicology

lGeneral Toxicology (in Rodents)

– Acute toxicology, sub-chronic toxicity studies and

chronic toxicity studies by oral and parenteral

routes

lLocal Tissue Tolerance Studies

– Sensitization Study in Guinea pigs

– Skin Irritation Study in Rabbits

lMutagenicity Studies

– In vitro: Ames and Mouse Lymphoma Tk assay

– In vivo: Micronucleus and Chromosomal

Aberration test

nBio efficacy studies of biotechnologically derived products

Leaflet 02 Back

The team of regulatory affairs professionals has to date

submitted data to the USFDA, MCA, DCG (India) and South

East Asia and has capabilities to assist in regulatory

submissions in the Asia-Pacific, the Middle East and the

European Union.

This facilitation includes

nConsultation, creation and defending of regulatory

submissions

lRegulatory review and support

– Consultation and planning

– Preparation / review of reports

– Bridging studies

– Report summarizations for IND submissions

lGlobal clinical trials regulatory submissions

– Approval of investigator packets required for

release of investigational products

– Development and review of 'informed consent'

forms

– Managing of regulatory requirements for specific

countries and regions

– Development, compilation and submissions of

regulatory applications

– Product registration

nPost-marketing surveillance services

lLiterature search

lCoding and training and consulting in coding

lData processing and reporting to regulatory authorities

lPeriodic safety update reports

nPost-approval services

lReview of promotional materials

lReview of label changes

lStrategic planning for new indications

Reliance Life Sciences Pvt. Ltd.

Dhirubhai Ambani Life Sciences Centre, Thane-Belapur Road,

Rabale, Navi Mumbai - 400 701, INDIA.

Tel: (IND)+91 22 6767 8000 • Fax: +91 22 6767 8299

Tel: (UK)+44 7920420911, +44 7717177123

Email: [email protected]

Website: www.relclin.com

Regulatory Affairs

We are experienced in global regulatory submissions and will facilitate all your regulatory affairs needs.

Page 5: We believe - rellife.com · 19cms X 28cms Leaflet 02 Front Laboratory Animal Research Services The Laboratory Animal Research Services (LARS) group provides in-vivo efficacy and pre-clinical

Leaflet 02 Front19cms X 28cms

Laboratory Animal Research Services

The Laboratory Animal Research Services (LARS) group provides in-vivo efficacy and pre-clinical safety studies for cell-based

therapies, proteins and chemical entities.

The LARS is a OECD- GLP certified Toxicology facility. It also has

Indian GLP certification. The animal facility is registered with the

Committee for the Purpose of Control and Supervision of

Experiments on Animals (CPCSEA) and conforms to its

guidelines.

LARS value proposition includes

nState-of-the-art, barrier maintained facility with robust

environmental monitoring system

nStudies in compliance with OECD principles of GLP

nConduct of chronic studies in Specific Pathogen

Free animals

nFully automated clinical and histopathology laboratory with

highly skilled pathologists and technicians

nHighly qualified professionals experienced in GLP certified

labs to conduct toxicity studies

nIndependent QA team to conduct study, process and

facility based inspections

The experience and capabilities include:

nRegulatory Toxicology

lGeneral Toxicology (in Rodents)

– Acute toxicology, sub-chronic toxicity studies and

chronic toxicity studies by oral and parenteral

routes

lLocal Tissue Tolerance Studies

– Sensitization Study in Guinea pigs

– Skin Irritation Study in Rabbits

lMutagenicity Studies

– In vitro: Ames and Mouse Lymphoma Tk assay

– In vivo: Micronucleus and Chromosomal

Aberration test

nBio efficacy studies of biotechnologically derived products

Leaflet 02 Back

The team of regulatory affairs professionals has to date

submitted data to the USFDA, MCA, DCG (India) and South

East Asia and has capabilities to assist in regulatory

submissions in the Asia-Pacific, the Middle East and the

European Union.

This facilitation includes

nConsultation, creation and defending of regulatory

submissions

lRegulatory review and support

– Consultation and planning

– Preparation / review of reports

– Bridging studies

– Report summarizations for IND submissions

lGlobal clinical trials regulatory submissions

– Approval of investigator packets required for

release of investigational products

– Development and review of 'informed consent'

forms

– Managing of regulatory requirements for specific

countries and regions

– Development, compilation and submissions of

regulatory applications

– Product registration

nPost-marketing surveillance services

lLiterature search

lCoding and training and consulting in coding

lData processing and reporting to regulatory authorities

lPeriodic safety update reports

nPost-approval services

lReview of promotional materials

lReview of label changes

lStrategic planning for new indications

Reliance Life Sciences Pvt. Ltd.

Dhirubhai Ambani Life Sciences Centre, Thane-Belapur Road,

Rabale, Navi Mumbai - 400 701, INDIA.

Tel: (IND)+91 22 6767 8000 • Fax: +91 22 6767 8299

Tel: (UK)+44 7920420911, +44 7717177123

Email: [email protected]

Website: www.relclin.com

Regulatory Affairs

We are experienced in global regulatory submissions and will facilitate all your regulatory affairs needs.

Page 6: We believe - rellife.com · 19cms X 28cms Leaflet 02 Front Laboratory Animal Research Services The Laboratory Animal Research Services (LARS) group provides in-vivo efficacy and pre-clinical

Bioavailability / Bioequivalence clinical studies and Early phase human clinical studies

The Clinical Pharmacology and Pharmacokinetic Services group is a full range service provider, from protocol development to

report preparation.

As an end-to-end Clinical Pharmacology and Pharmacokinetic

Services provider, we facilitate your abbreviated drug

development efforts, as well as early phase clinical studies. Our

Bioavailability / Bioequivalence units have been inspected and

approved by US FDA, MPA (Sweden), ANVISA (Brazil), MoH of

Turkey, Israeli regulatory authority and DCG(I).

These services include

nA 100-bed state-of-the-art clinical facility in Navi Mumbai

and Bangalore with four clinics for BA / BE studies,

including facilities for studies on female volunteers

nAn 10-bed ICU facility for Phase-I studies, along with a

complete cardiac monitoring and pharmacodynamic

center

nFully automated motorised ICU beds with centralized

oxygen/suction/air

nCentral data recording / retrieving system and data logging

system

nDigital continuous ECG recording system (Holter),

telemetry system, pulmonary function tests, nebuliser,

defibrillator, ventilator, infusion pump and ambulatory

BP monitor.

nComprehensive services, from study documents

development to report submissions to various regulatory

requirements

nDatabase of more than 3,500 registered healthy volunteers,

including 1,000 female volunteers

nR-Kinetics software for web-based documentation of

Screening, Pathology and Studies

nHighly equipped Bio-analytical division with highly sensitive

instruments like LCMS / MS with different ionization

techniques, and PDA, florescence and ECD detectors

nCAP and NABL accredited in-house diagnostic services.

nFully compliant processes and systems as per ICH,

USFDA, WHO, ANVISA (Brazil), MHRA (UK), MCC (South

Africa), TGA (Australia) and DCGI (India) norms

Proven expertise in

nMethod development and validation of more than 106

molecules

nHandling audits of USFDA, MCC, ANVISA, MPA, MOH

Turkey, Israeli regulatory authority and DCGI

nConduct of:

lSingle dose and multiple dose studies

lFood and Drug interaction studies

lSafety evaluation studies

lSpecial population studies

lUrine studies

Leaflet 03 Front Leaflet 03 Back19cms X 28cms

Cardiac Safety Studies

Several drugs have been pulled out from the market over the last few years over concerns that they may cause adverse cardiac

events. The implementation of the ICH E14 guidance has transformed cardiac monitoring in clinical trials. The Thorough QT/QTc

(TQT) Trial has become a critical component of EMEA and FDA submissions, creating increased focus on cardiac monitoring and

ECG quality throughout drug development.

RCRS is a Mortara-Certified Partner capable of collecting, processing, and transmitting annotated ECG data compliant with ECG

Warehouse requirements. The ECG Core Laboratory and integrated cardiac safety unit provide state-of-the-art facilities to support

TQT studies, operating to the standard required for uploading of datasets into the FDA's ECG Warehouse.

So, if your NCE development requires extensive cardiac monitoring, RCRS offers the expertise to guide you from development

through submission

Reliance Life Sciences Pvt. Ltd.

Dhirubhai Ambani Life Sciences Centre, Thane-Belapur Road,

Rabale, Navi Mumbai - 400 701, INDIA.

Tel: (IND)+91 22 6767 8000 • Fax: +91 22 6767 8299

Tel: (UK)+44 7920420911, +44 7717177123

Email: [email protected]

Website: www.relclin.com

Page 7: We believe - rellife.com · 19cms X 28cms Leaflet 02 Front Laboratory Animal Research Services The Laboratory Animal Research Services (LARS) group provides in-vivo efficacy and pre-clinical

Bioavailability / Bioequivalence clinical studies and Early phase human clinical studies

The Clinical Pharmacology and Pharmacokinetic Services group is a full range service provider, from protocol development to

report preparation.

As an end-to-end Clinical Pharmacology and Pharmacokinetic

Services provider, we facilitate your abbreviated drug

development efforts, as well as early phase clinical studies. Our

Bioavailability / Bioequivalence units have been inspected and

approved by US FDA, MPA (Sweden), ANVISA (Brazil), MoH of

Turkey, Israeli regulatory authority and DCG(I).

These services include

nA 100-bed state-of-the-art clinical facility in Navi Mumbai

and Bangalore with four clinics for BA / BE studies,

including facilities for studies on female volunteers

nAn 10-bed ICU facility for Phase-I studies, along with a

complete cardiac monitoring and pharmacodynamic

center

nFully automated motorised ICU beds with centralized

oxygen/suction/air

nCentral data recording / retrieving system and data logging

system

nDigital continuous ECG recording system (Holter),

telemetry system, pulmonary function tests, nebuliser,

defibrillator, ventilator, infusion pump and ambulatory

BP monitor.

nComprehensive services, from study documents

development to report submissions to various regulatory

requirements

nDatabase of more than 3,500 registered healthy volunteers,

including 1,000 female volunteers

nR-Kinetics software for web-based documentation of

Screening, Pathology and Studies

nHighly equipped Bio-analytical division with highly sensitive

instruments like LCMS / MS with different ionization

techniques, and PDA, florescence and ECD detectors

nCAP and NABL accredited in-house diagnostic services.

nFully compliant processes and systems as per ICH,

USFDA, WHO, ANVISA (Brazil), MHRA (UK), MCC (South

Africa), TGA (Australia) and DCGI (India) norms

Proven expertise in

nMethod development and validation of more than 106

molecules

nHandling audits of USFDA, MCC, ANVISA, MPA, MOH

Turkey, Israeli regulatory authority and DCGI

nConduct of:

lSingle dose and multiple dose studies

lFood and Drug interaction studies

lSafety evaluation studies

lSpecial population studies

lUrine studies

Leaflet 03 Front Leaflet 03 Back19cms X 28cms

Cardiac Safety Studies

Several drugs have been pulled out from the market over the last few years over concerns that they may cause adverse cardiac

events. The implementation of the ICH E14 guidance has transformed cardiac monitoring in clinical trials. The Thorough QT/QTc

(TQT) Trial has become a critical component of EMEA and FDA submissions, creating increased focus on cardiac monitoring and

ECG quality throughout drug development.

RCRS is a Mortara-Certified Partner capable of collecting, processing, and transmitting annotated ECG data compliant with ECG

Warehouse requirements. The ECG Core Laboratory and integrated cardiac safety unit provide state-of-the-art facilities to support

TQT studies, operating to the standard required for uploading of datasets into the FDA's ECG Warehouse.

So, if your NCE development requires extensive cardiac monitoring, RCRS offers the expertise to guide you from development

through submission

Reliance Life Sciences Pvt. Ltd.

Dhirubhai Ambani Life Sciences Centre, Thane-Belapur Road,

Rabale, Navi Mumbai - 400 701, INDIA.

Tel: (IND)+91 22 6767 8000 • Fax: +91 22 6767 8299

Tel: (UK)+44 7920420911, +44 7717177123

Email: [email protected]

Website: www.relclin.com

Page 8: We believe - rellife.com · 19cms X 28cms Leaflet 02 Front Laboratory Animal Research Services The Laboratory Animal Research Services (LARS) group provides in-vivo efficacy and pre-clinical

Clinical Trial Operations

We adopt stringent processes to ensure smooth operations across studies and leverage our strong relationships with investigators

and vendors to meet your clinical operations needs on time, every time.

The Phase II-IV Clinical Trial Operations group at Reliance

ensures accurate and timely delivery of clinical trial information

to sponsors. The group uses technology that allows careful and

continuous tracking, review, compilation and presentation of

clinical trial information from investigator sites to sponsors, at

any point during the trial.

Clinical Trial Operations services include

nMedical Writing, comprising:

lProtocol design

lReport writing

lWriting publications, marketing material and medical

training modules

nInvestigator and site selection, using our extensive

proprietary investigator database

nCo-ordination of investigator meetings that target

standardization of medical care around the protocol

nGrant negotiation and administration of investigator

payments

nClinical monitoring by office-based CRAs

nPharmacovigilance comprising:

l24-hour safety surveillance for Serious Adverse Events

lEffective on-site medical monitoring

lPost-marketing Pharmacovigilance as per European

regulations

nClinical Trial Supplies Management comprising:

lCustoms clearance and storage of clinical trial supplies

in a GMP-compliant depot

lFacility to store clinical trial material at -20°C, 2-8°C and

ambient temperatures

lComputerized, validated, 21 CFR part 11 compliant,

temperature monitoring systems to record 24x7

temperature and humidity

lLinkage to IVRS systems and timely distribution of

materials across India

lWell-defined access controls for controlled and

restricted access to authorized personnel

nRecords Management comprising:

lArchival facilities: paper and electronic files

lOffsite storage

Leaflet 04 Front19cms X 28cms Leaflet 06 Front19cms X 28cms

Biometrics

The Biometrics team is equipped with the Adverse Events Reporting System, as well as subscriptions to MedDRA and WHO-DD. From its inception in 2003, the team has completed over twenty large projects including meta-analyses.

We seek to provide cost-effective and cutting-edge data

management and analytical services to meet all your biometrics

needs through the discovery, research and development

stages. Our involvement begins with the planning of your study

and extends right up to supporting your study result

submissions. The data management and biostatistics services

are provided on the Oracle Clinical and SAS platform.

We offer value addition through:

nA full-fledged electronic data capture setup, besides

conventional paper CRF set up

nRobust validation methodology for early query resolutions

Training Reliance offers basic and advanced courses in Good Clinical Practices for the biopharmaceutical industry, institutional

ethics committee members and investigational site personnel. These courses focus on understanding the responsibilities of all

involved players towards ensuring safety, rights and well being of study participants and integrity of study data.

nEase of integration with coding dictionaries and external

data uploads

nIndustry standards for timelines for study lock and transfer

of data

nAutomatic / Interactive report generation by clinical teams

nBuilding a comprehensive data warehousing solution

nAnalytical models (data mining) for pattern detection during

early development, as well as clinical trials

Our Data Services include:

nBiostatistics

nStatistical Programming

nData Management

Reliance Life Sciences Pvt. Ltd.

Dhirubhai Ambani Life Sciences Centre, Thane-Belapur Road,

Rabale, Navi Mumbai - 400 701, INDIA.

Tel: (IND)+91 22 6767 8000 • Fax: +91 22 6767 8299

Tel: (UK)+44 7920420911, +44 7717177123

Email: [email protected]

Website: www.relclin.com

Page 9: We believe - rellife.com · 19cms X 28cms Leaflet 02 Front Laboratory Animal Research Services The Laboratory Animal Research Services (LARS) group provides in-vivo efficacy and pre-clinical

Clinical Trial Operations

We adopt stringent processes to ensure smooth operations across studies and leverage our strong relationships with investigators

and vendors to meet your clinical operations needs on time, every time.

The Phase II-IV Clinical Trial Operations group at Reliance

ensures accurate and timely delivery of clinical trial information

to sponsors. The group uses technology that allows careful and

continuous tracking, review, compilation and presentation of

clinical trial information from investigator sites to sponsors, at

any point during the trial.

Clinical Trial Operations services include

nMedical Writing, comprising:

lProtocol design

lReport writing

lWriting publications, marketing material and medical

training modules

nInvestigator and site selection, using our extensive

proprietary investigator database

nCo-ordination of investigator meetings that target

standardization of medical care around the protocol

nGrant negotiation and administration of investigator

payments

nClinical monitoring by office-based CRAs

nPharmacovigilance comprising:

l24-hour safety surveillance for Serious Adverse Events

lEffective on-site medical monitoring

lPost-marketing Pharmacovigilance as per European

regulations

nClinical Trial Supplies Management comprising:

lCustoms clearance and storage of clinical trial supplies

in a GMP-compliant depot

lFacility to store clinical trial material at -20°C, 2-8°C and

ambient temperatures

lComputerized, validated, 21 CFR part 11 compliant,

temperature monitoring systems to record 24x7

temperature and humidity

lLinkage to IVRS systems and timely distribution of

materials across India

lWell-defined access controls for controlled and

restricted access to authorized personnel

nRecords Management comprising:

lArchival facilities: paper and electronic files

lOffsite storage

Leaflet 04 Front19cms X 28cms Leaflet 06 Front19cms X 28cms

Biometrics

The Biometrics team is equipped with the Adverse Events Reporting System, as well as subscriptions to MedDRA and WHO-DD. From its inception in 2003, the team has completed over twenty large projects including meta-analyses.

We seek to provide cost-effective and cutting-edge data

management and analytical services to meet all your biometrics

needs through the discovery, research and development

stages. Our involvement begins with the planning of your study

and extends right up to supporting your study result

submissions. The data management and biostatistics services

are provided on the Oracle Clinical and SAS platform.

We offer value addition through:

nA full-fledged electronic data capture setup, besides

conventional paper CRF set up

nRobust validation methodology for early query resolutions

Training Reliance offers basic and advanced courses in Good Clinical Practices for the biopharmaceutical industry, institutional

ethics committee members and investigational site personnel. These courses focus on understanding the responsibilities of all

involved players towards ensuring safety, rights and well being of study participants and integrity of study data.

nEase of integration with coding dictionaries and external

data uploads

nIndustry standards for timelines for study lock and transfer

of data

nAutomatic / Interactive report generation by clinical teams

nBuilding a comprehensive data warehousing solution

nAnalytical models (data mining) for pattern detection during

early development, as well as clinical trials

Our Data Services include:

nBiostatistics

nStatistical Programming

nData Management

Reliance Life Sciences Pvt. Ltd.

Dhirubhai Ambani Life Sciences Centre, Thane-Belapur Road,

Rabale, Navi Mumbai - 400 701, INDIA.

Tel: (IND)+91 22 6767 8000 • Fax: +91 22 6767 8299

Tel: (UK)+44 7920420911, +44 7717177123

Email: [email protected]

Website: www.relclin.com

Page 10: We believe - rellife.com · 19cms X 28cms Leaflet 02 Front Laboratory Animal Research Services The Laboratory Animal Research Services (LARS) group provides in-vivo efficacy and pre-clinical

Central Molecular Laboratory Services

Our diagnostic services are CAP and NABL accredited and comply with international quality standards (ISO / IEC 17025, 1999).

Reliance has CAP and NABL accredited diagnostics laboratory

services. Molecular Diagnostics and Genetics Testing services

are conducted for South and South East Asia.

The laboratory services include

nGenetic Diseases – Adults / PND

lKaryotyping & FISH Based Tests for Aneuploidy

nInfectious Diseases

lViruses Qual./Quant./Genotyping

lBacteria- Mycoplasma TB,

lProtozoa- Plasmodium spp.

nMutation Detection Nucleotide

lSequencing

lMitochondrial Mutation

lBeta Thalassemia Mutation, DMD - Deletions

lHuntington's Disease, BRCA1/2Mut., Ret mut.

nFlow Cytometry

lCD3/CD4/CD8

lImmunotphenotyping –

lLeuk./Lymphomas

nCancer Tissue Biomarkers

lHNE / IHC / FISH (Her2/Neu;

Bcr.abl., PML.RARA)

nPharmacogenomics

lGenotyping – CYP2C9; CYP2C19;

lCYP2D6; CYP3A4; VKORC1

nPredictive/Preventive Biomarkers

lHPV in cervical cancer

lRet mutations in high risk families

lBeta Thalassemia mutation in foetal tissues

lDMD deletions in foetal tissues

lBRCA1/2 mutation in familial Breast Ca.

lK-ras mutation in metastatic colon Ca.

nTranslational Research

lWhole Genome Genotyping +/-

lWhole genome expression

lOral Cancer / Lung Cancer

lDiabetic Retinopathy

lVitiligo

lCardiovascular diseases

Leaflet 05 Front Leaflet 05 Back19cms X 28cms

Reliance Life Sciences Pvt. Ltd.

Dhirubhai Ambani Life Sciences Centre, Thane-Belapur Road,

Rabale, Navi Mumbai - 400 701, INDIA.

Tel: (IND)+91 22 6767 8000 • Fax: +91 22 6767 8299

Tel: (UK)+44 7920420911, +44 7717177123

Email: [email protected]

Website: www.relclin.com

The Central Pathology Laboratory is CAP accredited and

compliant with NABL standards It has the expertise to meet

the requirements of various regulatory bodies.

n21-parameter, five-part differential haematology analyzer

nFully automated biochemistry analyzer

nAutomated urine analyzer

nFully automated 4 plate ELISA processor

nDirect interfacing of instruments with LIS

nPCR for variety of investigations including HIV,HAV,

HBsAg, HCV

Pathology laboratory services

Our diagnostic services are CAP and NABL accredited and comply with international quality standards (ISO / IEC 17025, 1999).

Page 11: We believe - rellife.com · 19cms X 28cms Leaflet 02 Front Laboratory Animal Research Services The Laboratory Animal Research Services (LARS) group provides in-vivo efficacy and pre-clinical

Central Molecular Laboratory Services

Our diagnostic services are CAP and NABL accredited and comply with international quality standards (ISO / IEC 17025, 1999).

Reliance has CAP and NABL accredited diagnostics laboratory

services. Molecular Diagnostics and Genetics Testing services

are conducted for South and South East Asia.

The laboratory services include

nGenetic Diseases – Adults / PND

lKaryotyping & FISH Based Tests for Aneuploidy

nInfectious Diseases

lViruses Qual./Quant./Genotyping

lBacteria- Mycoplasma TB,

lProtozoa- Plasmodium spp.

nMutation Detection Nucleotide

lSequencing

lMitochondrial Mutation

lBeta Thalassemia Mutation, DMD - Deletions

lHuntington's Disease, BRCA1/2Mut., Ret mut.

nFlow Cytometry

lCD3/CD4/CD8

lImmunotphenotyping –

lLeuk./Lymphomas

nCancer Tissue Biomarkers

lHNE / IHC / FISH (Her2/Neu;

Bcr.abl., PML.RARA)

nPharmacogenomics

lGenotyping – CYP2C9; CYP2C19;

lCYP2D6; CYP3A4; VKORC1

nPredictive/Preventive Biomarkers

lHPV in cervical cancer

lRet mutations in high risk families

lBeta Thalassemia mutation in foetal tissues

lDMD deletions in foetal tissues

lBRCA1/2 mutation in familial Breast Ca.

lK-ras mutation in metastatic colon Ca.

nTranslational Research

lWhole Genome Genotyping +/-

lWhole genome expression

lOral Cancer / Lung Cancer

lDiabetic Retinopathy

lVitiligo

lCardiovascular diseases

Leaflet 05 Front Leaflet 05 Back19cms X 28cms

Reliance Life Sciences Pvt. Ltd.

Dhirubhai Ambani Life Sciences Centre, Thane-Belapur Road,

Rabale, Navi Mumbai - 400 701, INDIA.

Tel: (IND)+91 22 6767 8000 • Fax: +91 22 6767 8299

Tel: (UK)+44 7920420911, +44 7717177123

Email: [email protected]

Website: www.relclin.com

The Central Pathology Laboratory is CAP accredited and

compliant with NABL standards It has the expertise to meet

the requirements of various regulatory bodies.

n21-parameter, five-part differential haematology analyzer

nFully automated biochemistry analyzer

nAutomated urine analyzer

nFully automated 4 plate ELISA processor

nDirect interfacing of instruments with LIS

nPCR for variety of investigations including HIV,HAV,

HBsAg, HCV

Pathology laboratory services

Our diagnostic services are CAP and NABL accredited and comply with international quality standards (ISO / IEC 17025, 1999).

Page 12: We believe - rellife.com · 19cms X 28cms Leaflet 02 Front Laboratory Animal Research Services The Laboratory Animal Research Services (LARS) group provides in-vivo efficacy and pre-clinical