| Clinical Research is a branch of science that determines the safety and effectiveness of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease. |
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| The mission of Surya Pharmaceutical Ltd, is to enhance quality of life by upgrading techniques and procedures in its new Clinical Research wing . |
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| In our clinical Research wing, utmost care is taken to ensure the validity of all the research projects and to ensure full compliance with applicable national and international regulations and statutory requirements. We hope to create benchmarks and mold the future of clinical research industry. |
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| Our Values |
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- Respect for people and ethical business practices.
- To demonstrate the utmost Integrity in all business practices.
- To pursue excellence through a continual focus on Quality and innovation.
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| Our Mission |
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- To build and develop a spirit of teamwork in our people to achieve and exceed our goals.
- To develop the technical knowledge and skill through extensive training and to have adequate exposure to the existing developments in the different areas of operations.
- To integrate our quality initiatives and processes and internalize them in every aspect of our work.
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| The Fact Sheet |
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| Surya Pharmaceutical Limited was established in 1992, with a vision towards Empowering Life and well being, and has rapidly emerged as the premier integrated pharmaceutical company in India. Its business focuses on the manufacture and marketing of pharmaceutical products and services to clients across the globe, and its product & services portfolio includes a range of Active Pharmaceutical Ingredients (APIs), Intermediates, Branded Ethical Formulations, Phyto Pharmaceuticals and Contract Research and Manufacturing Services. The company is one of the largest manufacturers and exporters of Mint/Menthol derivatives and also manages state of the art research&development centres that offer the highest quality of Contract Research and Manufacturing Services. Over the years, Surya Pharmaceutical Limited has established a global footprint in fulfilling the requirements of clients across 90 countries.: |
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Company Facts:
Founded : In 1992. |
| Operations:Surya Pharmaceutical Limited is headquartered in Chandigarh(India) with a multi- state manufacturing presence in the states of Himachal Pradesh, Haryana, Punjab and Jammu& Kashmir. It has six manufacturing units for Intermediates, APIs, Menthol and its Derivatives, Formulations and two Research & Development Centres. Now, Surya Pharmaceutical Limited also plans to launch a new clinical research unit. It will be dedicated to offering Central Laboratory Services to support the needs of development for various Phases of Clinic Trials. Our service capabilities extend to support Mulitcentric Clinical Trials with sites in India. |
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| The new clinical research unit of Surya Pharmaceutical Limited will strengthen Surya's position as one of the leading exporters of pharmaceutical products with its network of overseas offices to China,Singapore and a new state -of- the art Research and Development Centre set up at San Diego, USA named Surya BioPharma USA Inc . Divisions-The new clinical research wing of Surya Pharmaceutical Ltd will give its clients, the flexibility and ease of working with a high-profile team of technically experienced people ,which will give them the assurance of being provided with world-class service along with reliable results. This has established Surya's position as an accomplished Global Leader. |
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| Our services |
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| Biostatistics & Programming: |
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| Capabilities: |
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Supports clients through the entire process of drug discovery and development of medical devices, spanning all phases of clinical research Comprehensive support for bio availability studies, all phases of clinical trials in patients, as well as pre-clinical animal studies Support on fixed sample size trials, sequential studies and adaptive designs
Department is furnished with SAS version 9.1.3 for randomization, statistical analysis, TLGs and sample size calculation and WinNonlin version 5.0.1 for PK/PD analysis |
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| Why us? |
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Specialised in providing sophisticated statistical analysis planning and execution
High quality data presentation and statistical report writing in accordance with global regulatory standards
Team comprises of qualified/trained statisticians and SAS Programmers
Clients trust Divisions to provide technical expertise, efficiency and flexibility with an emphasis on quality and timeliness |
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| Bio analytical Services: |
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| Capabilities: |
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Ability to develop and validate methods well in advance based on patent expiry and business sense
Ability to accommodate urgent bio equivalence projects
State-of-the-art Instrumentation available.
Scientific Data Management System. |
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| Services: |
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Method development/Method validation Method transfer for drugs in biological matrix
LC-MS/MS and HPLC analysis of drug and metabolites in biological matrix from clinical trials
Sample storage at -20° C and -80° C. |
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| Why us? |
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Rapid turn-around-time
Capability to handle liquid-liquid extractions, solid phase extractions and derivatization procedures
Chiral separations of optical isomers
Estimation of conjugated and non-conjugated drug levels
Customized assay method
Expertise in different matrix handling
Expertise in handling regulatory audits
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| Central Reference Laboratory: |
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| Capabilities: |
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Clinical biochemistry
Immuno hematology
Immunology & Serology
Flowcytometry
Molecular biology
Microbiology
Biomarkers |
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| Experience: |
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| The Central lab at Surya Divisions has vast experience in various clinical trials involving specialties like COPD, CVS, Oncology, Diabetes, CNS, Orthopedics, etc. |
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Central laboratory services
Pathology
Investigators support and supplies
Consulting & project management
Advanced logistics support
Laboratory data management solutions
Sample storage & archiving solutions
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| Clinical Data Management: |
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| Services: |
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Data entry services
Coding of adverse events and medications
Lab data transfers per sponsor's specifications
Clinical programming
Complete clinical data management services |
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| Why us? |
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Ability to support operations round the clock
Equipped with latest industry leading software tools deployed in a validated environment
Certified clinical data managers
Trained and certified in implementation of CDISC standards
Strong team of experts who focus on innovative procedure to ensure 100% quality services
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| Project Management and Pharmacokinetics: |
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| Capabilities: |
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Innovative client-centric account management system
Translation of clients' requirements into practical project plans
Assiduous planning, execution and tracking of various stages of projects One-stop compilation and dispatch cell delivering ICH compliant study reports
Trained pharmacokinetic personnel
Electronic archiving services transforming large clinical study data into compact digital forms
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| Services: |
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Client-specific account management
Meticulously planned projects
Organized tools for planning, tracking and coordination
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| Why us? |
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Effective levels of communication
Rapid turn-around-time for final reports backed-up by well designed infrastructure
Latest in technology and well-proven data management services
Quality documentation within competitive time-frame
Customized solutions to all your needs in clinical research
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| Quality Assurance: |
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| Capabilities: |
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Independent QA function at all sites
Adequate safety measures & temperature/humidity monitoring facility
Well structured QA audits at pre-defined intervals to ensure data integrity
Regular system audits to facilitate continuous system improvements
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| Why us? |
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Dedicated, qualified & well trained QA auditors
Teams with well defined job responsibilities for conducting internal audits (Clinical Pharmacology & Medical Affairs, Clinical Trials Management, Clinical Laboratory, Clinical Data Management, Bioanalytical,Project Management & Pharmacokinetics and Biostatistics & Programming)and document control .
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| Pharmacovigilance: |
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| Capabilities: |
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Risk Management Statements
Drug Safety Database Management
Serious Adverse Event Processing
Huge pool of experience
SAE/ADR: Receipt and Triage, Data-Entry, Narrative Writing, Medical Review including Label Assessment, Causality Statement, Quality Control, Submission to Health Authorities
ICSR Handling
Literature search
PSUR generation
Signal detection and evaluation
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| Clinical Trials : |
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| Capabilities: |
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Customer driven services from an experienced team of clinical
research professionals
Operations regionally based in India
Project manager lead team-based relationships
Strong experience in conducting multi-national, multi-centric clinical trials
Patient based pharmacokinetic studies |
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| Services: |
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Project management
Protocol development
Feasibility services
Regulatory documentation
IRB submission
Investigator meetings
Site initiation
Clinical monitoring
Central IMP storage & distribution services
Patient based pharmacokinetic studies
Central laboratory services
QTc studies & ECG core laboratory services
Data management services
Medical writing services |