CENTRAL BIOANALYTICAL SERVICES
We offer Central Bioanalytical services as a part of its Speciality Service offering. We have a credible and longstanding experience of importing PK samples from across the Globe into the Bioanalytical Lab at Ahmedabad, India for the purpose of Bioanalysis and quantification of analyte(s) of interest. We also
have an experience of working for 10 of the Top 15 Global Major Pharmaceutical Companies as a Central Bioanalytical Lab. Service delivery according to Client’s SOPs has always been a part of Veeda CR’s Quality system, to facilitate Research at acceptable standards and controls, for various Global Clients.
Veeda has an impeccable experience as a team experienced with over 1625+ Clinical studies ranging from BA/BE to Human Pharmacology Studies. Overall combined experience of all the senior personnel is more than 100 man working years in Pharmaceutical companies and CROs put together.
With such a depth in technical and regulatory insight, we have
now launched this new speciality service as a part of our value-added service offering to our clients to work with them in the generic drug development process. We differentiate ourselves by adding depth and breadth to our services which would result in a higher success rate in BA/BE studies and speed to market for our sponsors.
Considering the overall diversity in service offerings as Knowledge based CRO, Veeda now offers a fortified basket of offerings in the areas of:
- Study Designs
- Medical Writing
- Statistical Concepts
- Data Evaluation
- Regulatory Aspects
Through this service, we can provide strategized solutions in generic drug development process by providing better alternatives / approaches in the mentioned areas. Moreover, we have also initiated building our processes for IVIVC offering as well.
QUALITY ASSURANCE SERVICES
Veeda has a very well established Quality management system with well-developed procedures and policies to ensure protocol adherence and compliance with International regulatory guidelines. We have competent Quality professionals with hands-on experience in GCP and ISO systems. We have an experience of working in all the phases of clinical research including Clinical Data Management, 21 CFR Part 11 compliance, bioanalysis, Pharmacokinetics and Statistical analysis, Software validation and diversified auditing methods. Additionally,
we have an experience of conducting study audits for more than 1625+ clinical studies and have an experience of working in various geographies across the globe. Veeda’s QA team has experience in QMS setup, auditing and software validation assignments in USA, UK, Belgium, Germany and India. Our auditing experience includes USFDA, UKMHRA, EU, ANVISA, WHO, MCC submission studies. Veeda’s QA team has successfully faced USFDA, WHO, UKMHRA, AGES, ANSM, MCC, ANVISA, NPCB inspections.
VEEDA CR QUALITY ASSURANCE TEAM CAN OFFER THE FOLLOWING SERVICES TO OUR CLIENTS:
QMS design and Management Services:
- Process Mapping
- Document Management Process set-up.
- Identification and Development of Quality Policies and SOPs
- Training on QA aspects
- Gap identification and mitigation in established systems
- GCP / GCLP, Part 11 compliance audits.
- CDM and EDC audits
- BA/BE study audits
- Clinical Trial site audits
- Mock inspections/pre-regulatory audits
- Vendor audits
- Pathology lab audits (NABL/CAP)
21CFRPart11 Compliance Support:
- Computer system validation services
- Software validation QA services
PROJECT MANAGEMENT SERVICES
Veeda has a highly competent Project Management team who has managed complex projects with great finesse and accuracy. We have a separate Project Management Group which oversees the entire project flow right from the stage of first Client Interaction till final report dispatch to the cli¬ent. We also offer post-submission query resolution support through till facing the Regulatory authorities till product approval.
Veeda offers the concept of Client-specific Project Managers, increasing the ease of communication. The stability of our Project Management team is exceptional with < 10% attrition in the Project Management team which ensures single-point contact for the clients. With all the mentioned attributes, Veeda offers Project Management services to the Clients who wish to have a world-class scientific Project Manager managing their projects.
The unique features of our Project Management group are as below:
- Scientists having hands-on experience become Project Managers
- All the Project Managers are either Post-graduates and / or pursuing Doctorate studies, by education.
- Have in-depth understanding of study designs, statistical concepts, reporting requirements, regulatory aspects and Business nuances.
- Exceptional communication skills with Openness and transparency.
- Personable and committed to clients.