Gratisol
Gratisol Labs is a leading Resource Consulting Services organization for the IT, Pharmaceutical, Biotechnology and Medical Device industries. Gratisol Labs has developed a tailored training division ‘Gratisol Health Sciences Center of Excellence’ to provide value based Training, Internships, & Educational programmes in concepts of pharmaceutical industry (like cGMP, GLP, GAP, GCP, Regulatory Affairs, Instrumental Analysis( HPLC,GC,UV,IR), Method Development, Method Validation, Research & development etc). [1]
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| Type | Privately Held |
| Headquarters | Telangana |
| Number of employees | 11-50 employees |
Services Offered
- Recruitment Solutions
- Temporary Staffing
- Outsourcing
- Consulting
- Training in Clinical operations
- Clinical Data Management
- Pharmacovigilance
- Regulatory Affairs
- Medical Writing
- CDISC SDTM & SAS to aspirants of Clinical Research Industry [2]
Specialties
- Clinical Data Management
- Clinical Research Staffing Services
- Pharmacovigilance & Drug Safety
- Corporate Training
- Recruitment
- Expert Hands on Training on HPLC
- Gas Chromatography
- Wet Analysis
- Residual Solvent
- Herbal R&D
- Manufacturing of Herbal Cosmetics
Pharmacovigilance
Gratisol Labs offers complete Pharmacovigilance services, which include data collection, processing, medical review, safety writing, report writing, reporting, signal detection and analysis.
Following the recent withdrawals of many blockbuster drugs, Pharmacovigilance has become a critical phase in the Clinical Development Programs of pharmaceutical companies. The regulations on safety monitoring have become stringent and are periodically revised. This has led to increased safety data collection, analysis and regulatory surveillance, which in turn has increased costs. You, therefore, need a strategic partner with process expertise–one who can minimize your cost pressures while unlocking value and maintaining compliance.
Gratisol Labs Pharmacovigilance is uniquely focused on providing comprehensive and customized Pharmacovigilance (PV) services and offering specialized services to augment or support any drug safety department, tailored to fit your needs.
Experienced and qualified project managers are your primary contact point; they are responsible for project initiation, continued management of your PV needs and will anticipate potential future needs.
The monitoring of clinical trial safety and the continuing post marketing safety are vital responsibilities for pharmaceutical companies. However, the regulatory requirements have become increasingly complex in recent years and expert knowledge is needed to fulfill the stringent obligations. Gratisol Labs’ Pharmacovigilance team is comprised of Medical & healthcare professionals with vast experience in both direct patient care and industry-specific Pharmacovigilance services, which enables us to provide you with the highest quality safety surveillance services. Clinical Trial Safety:
- Serious adverse event (SAE) management including collection, documentation, active query process and follow-up
- SAE processing within required timeframes in client's database (e.g. Clintrace™ and ARISg™, Argus Safety Database) and other non-commercial systems.
- Qualified medical review of all SAEs for data completeness and medical sense
- Appropriate Medical Dictionary for Regulatory Activities (MedDRA) coding
- Regulatory reporting to authorities, investigators and ethics committees
- Electronic safety reporting according to ICH E2B
- Preparation and submission of annual safety reports (ASRs)
- Data reconciliation of Pharmacovigilance and clinical trials databases
- Writing of patient safety narratives for study reports
- Project-specific standard operating procedures (SOPs)
- Compliance monitoring
- SAE training for investigators and monitors
Post Marketing Safety:
- Processing and reporting of adverse drug reactions (ADRs) from the post marketing area In Gratisol Labs global safety database.
- In client‘s database via remote access
- Electronic safety reporting according to ICH E2
- Compliance monitoring
- Preparation of periodic safety update reports (PSURs)
- Evaluation of signals with respect to the need to update the Company Core Safety Information (CCSI)
- Periodic signal detection activities for medicinal products with a marketing authorization
- Literature review in collaboration with a dedicated literature service provider
- Preparation and Update of risk management plans (EU-RMP)
IT Infrastructure and Safety Database:
Do you need comprehensive end-to-end Pharmacovigilance services to meet the demands of the worldwide regulatory authorities?
Our global drug safety database helps you to track, process and report adverse events in your client specific database instance. We can support you in building your own in-house Pharmacovigilance program (PV database implementation and validation). For established PV departments, our specialized IT communication and access support has acquired the expertise and tools necessary to meet new challenges in enabling secure communication and ensuring secure remote access to your safety database
Global Drug Safety Database:
Our global drug safety database provides you with a tailor-made and cost-effective drug safety solution for small- and mid-size pharmaceutical companies.
- Complete PV software system
- Web-based tool to capture, manage, evaluate and report ICSRs according to regulations and internal needs; custom made workflow and user groups
- Validated and 21 CFR part 11-compliant environment
- Highest security standards
- Global regulatory reporting pre- and post marketing (CIOMS I form, MedWatch form, etc.)
- Electronic safety reporting according to E2B standard (XML message)
- E2B interchange module (from 2011 onwards)
- Validated reports for data retrieval and compliance report
- Regular MedDRA updates
- Extensive quality control built-in (field validation, pre-save and post-save checks)
- Client-specific database instances
Reference
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