- Phone
- +91-40-65...
- Send email
- Web
- Visit website
- Country
- IndiaIndia
- Address
-
#102 Meera Mansions
Civil Supplies Bhavan Lane
Erramanzil
Somajiguda
Hyderabad-500082
AP
Is this your business? Update this listing
India Near None
Company Description
Sanjeevani Bio Services Pvt Ltd aims
to be the best and foremost contract research organization committed to
serve the pharmaceutical industry worldwide with high quality
standards, at par with the international regulatory and professional
expectations.
cover Protocol and Case Report Form design, Monitoring, Report of
serious Adverse Events, Data Management and Statistics, Development and
implementation of Phase I-IV clinical trials, project management,
contract development and negotiation, budgeting, study and site
feasibility assessments, investigator selection, CRF development, study
monitoring, monitoring reports revision, training providing, statistical
analysis (SAS).
Sanjeevani Bio Services Pvt Ltd Provides services such as:
Trial Management
U.S. and International Clinical Trials
Investigator Selection
Database of Experienced Investigators
Wide Geographic Distribution
Grant and Contract Administration
Coordination of Study Drug Labeling, Packaging and Distribution
IRB Submissions
Regulatory Document Processing
Investigator Meeting Coordination and Conduct
Site Management
Pharmacovigilance
Customized Reports
Project Tracking Reports
Comprehensive Project Status Reports
Clinical Monitoring
Sanjeevani Bio Services Pvt Ltd functions with a regionally based monitoring system. Our CRAs are required to have two or more years of field monitoring experience. We have a QC monitor evaluation process to supplement individual monitor training, in order to maintain the highest quality standards. CRAs are required to be certified in all regulatory guidelines:
GCP
CFR
ICH
Our CRAs are able to conduct all aspects of clinical monitoring according to SOP's, such as:
Complete Monitoring Activities Associated with Phase I-IV Clinical Research Trials
Pre-study Site Evaluation and Investigator Assessments
Site Training
Site Initiation, Interim Monitoring and Close-Out Visits
100% Source Document Review and Data Verification
QC Visits
Drug Accountability
Clinical Data Management
Detailed CRF Design and Review
21 CFR Part 11-Compliant Systems
Double-Data Entry
EDC with Flexible Reporting
Comprehensive Data Validation
Dictionary Preferred-Term Coding
Electronic Data Integration and Transfer
Customized Data Listings
Assurance of Sponsor Confidentiality
Clinical Biostatistics
Protocol Development and Review
Study Design and Sample Size Estimation
Randomization Procedures
Statistical Analysis
SAS Programming
Client Customized SAS Datasets
Data Listings/Tables
Graphical Data Presentations
FDA Representation
Responsive, Interactive Statistical Consulting on Demand
Medical Writing & Regulatory Services
Investigators' Brochures
Protocols
IND Preparation and Administration
Integrated Clinical and Statistical Reports
e-CTD Compilation and Administration
Regulatory Consulting
Regulatory Submissions (NDA, PLA, PMA, ANDA)
Manuscripts
ICH-compliant Documents
Posters and Publications
Quality Assurance
Clinical Quality Assurance Audits
Protocol, Source Document and Case Report Forms
Data Listings and Tables
Database Audit Summary
Integrated Reviews of Study Report
Investigator Site Audits for Conformance with Good Clinical Practices (GCPs), International Conference on Harmonisation (ICH) and local government Guidances and regulations
SOP and Regulatory Compliance
Vendor Inspections
Is this your business? Update this listing