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![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](https://reader030.fdocuments.us/reader030/viewer/2022041123/5d220fae88c99339278daf5b/html5/thumbnails/1.jpg)
![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](https://reader030.fdocuments.us/reader030/viewer/2022041123/5d220fae88c99339278daf5b/html5/thumbnails/2.jpg)
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](https://reader030.fdocuments.us/reader030/viewer/2022041123/5d220fae88c99339278daf5b/html5/thumbnails/3.jpg)
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](https://reader030.fdocuments.us/reader030/viewer/2022041123/5d220fae88c99339278daf5b/html5/thumbnails/4.jpg)
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](https://reader030.fdocuments.us/reader030/viewer/2022041123/5d220fae88c99339278daf5b/html5/thumbnails/5.jpg)
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](https://reader030.fdocuments.us/reader030/viewer/2022041123/5d220fae88c99339278daf5b/html5/thumbnails/6.jpg)
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](https://reader030.fdocuments.us/reader030/viewer/2022041123/5d220fae88c99339278daf5b/html5/thumbnails/7.jpg)
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](https://reader030.fdocuments.us/reader030/viewer/2022041123/5d220fae88c99339278daf5b/html5/thumbnails/8.jpg)
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](https://reader030.fdocuments.us/reader030/viewer/2022041123/5d220fae88c99339278daf5b/html5/thumbnails/9.jpg)
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](https://reader030.fdocuments.us/reader030/viewer/2022041123/5d220fae88c99339278daf5b/html5/thumbnails/10.jpg)
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](https://reader030.fdocuments.us/reader030/viewer/2022041123/5d220fae88c99339278daf5b/html5/thumbnails/11.jpg)
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](https://reader030.fdocuments.us/reader030/viewer/2022041123/5d220fae88c99339278daf5b/html5/thumbnails/12.jpg)