Our QA team delivers strategic strength to our operation to ensure any day of compliance. QA group strives to keep COD Research’s head high in the industry via quality by design concept as an enabler.
Our systems are flexible enough to foster steady improvement and are firm enough to ensure quality and compliance.
Quality Assurance
Services
● Client Audits
● SDEA/ Partner Audits
● QMS Setup
● Vendor Qualification
● Alliance Partners Due Diligence
● Computer System Validation
● Pre-Audit/Inspection Readiness
● Change Management
● Deviation Management
● Gap Analysis
● Investigator Site Audits
● Regulatory Document Audits ( IBs, regulatory submission documents, PSMF etc.)
● GxP Trainings
Project Specific Quality Compliance Assessments
● Pharmacovigilance Audits
● Alliance Partner/ Business Partner Audits
● Project specific consultancy service tailored to the client’s requirement
● Review of Essential Documents
● Vendor Due Diligence
● TMF Assessments
● Clinical Trial Site Assessments
GxP/Compliance Audits
● Investigator Site Audit
● Client Audit
● Alliance Partner/ Business Partner Audit
● PSMF Gap Assessment
● QMS/ Process System Compliance Audits
● Pharmacovigilance Audit
● Vendor Audit
● Trial Master File Audit
● Database and Document Audit
● Effectiveness Audits of QMS
● Corrective Actions & Preventive Actions (CAPA)
Quality Assurance Services
● Client Audits
● SDEA/ Partner Audits
● QMS Setup
● Vendor Qualification
● Alliance Partners Due Diligence
● Computer System Validation
● Pre Audit/Inspection Readiness
● Change Management
● Deviation Management
● Gap Analysis
● Investigator Site Audits
● Regulatory Document Audits ( IBs, regulatory submission documents, PSMF etc.)
● GxP Trainings
Project Specific Quality Compliance Assessments
● Pharmacovigilance Audits
● Alliance Partner/ Business Partner Audits
● Project specific consultancy service tailored to the client’s requirement
● Review of essential documents
● Vendor Due Diligence
● TMF Assessments
● Clinical Trial Site Assessments
● Process Level Assessments
GxP/Compliance Audits
Being in this industry for so long, we know that patient engagement plays a vital role in clinical trial success, impacting everything from recruitment to advocacy.
● Patient enrolment (Recruitment and Retentions)
● Patient referral strategies (Direct-To-Patient-Recruitment) for rare disease
● Patient awareness and support
● Decentralized/Patient-centric approaches to ensure ease of participation and compliance
● Supporting Technological advancements (e-diaries, wearable devices, etc.)
Different models
to meet diverse needs
to meet diverse needs
Insights &
Resources
Request For Proposal
We offer an array of niche and full-fledged CRO services, from clinical trial protocol development to post-marketing surveillance. Whatever your need, rope in COD Research experts to breeze through regulatory approvals and get your drug or device on the market soon.
