VAATSALYA CLINICAL

is an audit, compliance and technical consulting firm serving the pharmaceutical, medical device and diagnostic and over-the-counter drug industries. Since 2005, we have helped domestic and international clients to achieve compliance with GxP Practices and other regulatory requirements to ensure the quality of their products.

 

VAATSALYA CLINICAL provides a full range of consulting and technical services. Our participation ranges from guidance and advice, to on-site collaboration and training, to turnkey  delivery.

 

Clinical Monitoring: The Clinical Monitoring group comprises of Monitors as Associates (senior and junior) and Clinical Trial Assistants. The primary responsibility of this group is to monitor sites to ensure collection of clinical data that is ICH GCP and protocol compliant. The team members are trained intensively, before being assigned the responsibility of monitoring sites, first in ICH-GCP guidelines and then as per Code of Federal Regulations, Title 21:

Part 11, “Electronic Records; Electronic Signatures”

Part 50, “Protection of Human Subjects”

Part 56, “Institutional Review Boards“

Part 809 In Vitro Diagnostics Product for Human Use

Part 820 medical devices

CPGM 7348.811, “Clinical Investigators”

 

Vaatsalya Clinical study monitors conduct the following :

Site Qualification Visits
EC submissions and approvals
Site Initiation Visits
Routine Monitoring Visits
Investigational Product and Materials accountability
Tracking and review of completed CRFs
GCP compliance at site and site staff training
Identification of unresolved issues
Source document verification
Site Closeout Visits
Site management activities

 

Quality Strategy

Similar to our clients, our Auditing Goal is to comply with 21 CFR Part 50, “Protection of Human Subjects”. We accomplish this through Quality Systems-Based Audits (not just simple checklists) that focus on proactively identifying the risks and non-compliance that compromise patient safety and product efficacy. Whether auditing against your Protocols or Standard Operating Procedures, Industry Standards or Regulatory Laws, Vaatsalya clinical independently assesses your compliance level while also providing valuable recommendations for improvement.

Our Auditing Experience represents the three primary sides of Compliance:

The US Food and Drug Administration – Consumer Safety Officers

Major US Pharmaceutical Manufacturer – Senior Clinical Research Associates

Independent Auditors

Our Auditing output Includes:

 

Audit Schedule

Audit report with Graded Compliance Findings Report along with the specified guidelines.

Recommendations for Improvement and Achieving Compliance

Overall Assessment Consistent as per the sponsor request.

Close-Out of the audit reports