Quality & Compliance

Regulatory-Grade Biospecimen Operations, Built for Trust

Clin Vedica Life Sciences embeds ethics, quality, and regulatory alignment into every stage of biospecimen procurement, handling, and data management—so your studies are supported by samples you can stand behind.

From ethics approvals and informed consent to biosafety and documentation, our framework is designed to meet the expectations of sponsors, investigators, and regulatory bodies.

A Structured Framework for Ethical, High-Quality Biospecimens

Our quality and compliance framework brings together national ethical guidance, international best practices, and robust internal SOPs. Every project is evaluated not only for scientific feasibility but also for ethical, regulatory, and operational fit.

We collaborate closely with investigators, institutional ethics committees, and sponsors to ensure that biospecimen procurement respects donor rights, maintains biosafety, and supports audit-ready documentation.

Key Outcomes of Our Framework

  • • Ethically sourced human biospecimens with informed consent.
  • • Traceable sample lifecycles from collection through shipment.
  • • Robust documentation for audits and regulatory submissions.
  • • Reduced pre-analytical variability through standardized SOPs.
  • • Protection of donor privacy and data confidentiality.

Ethics, Governance & Donor Protection

Respect for donors is central to every Clin Vedica engagement. Our processes are grounded in national ethical guidelines for biomedical and health research, and aligned with globally recognized principles for research involving human participants.

  • • Ethics committee (IRB/IEC) approvals obtained for prospective collections where required.
  • • Informed consent processes conducted by qualified site staff using approved documents.
  • • Use of de-identified or coded samples, with restricted access to re-identification keys.
  • • Clear definition of permitted research uses within consent and site agreements.
  • • Governance mechanisms for handling withdrawals, complaints, or protocol deviations.

Compliance Touchpoints for Every Project

  1. Ethics and regulatory review of the project outline.
  2. Verification of site capabilities, approvals, and SOPs.
  3. Training and alignment calls with site personnel as needed.
  4. Ongoing oversight for protocol adherence and documentation.
  5. Formal close-out with document archival and data retention controls.

Quality Management, SOPs & Pre-Analytical Control

Pre-analytical variability is one of the biggest risks to biospecimen-driven research. Clin Vedica mitigates this risk through standardized procedures and continuous quality oversight.

  • • Documented SOPs for collection, processing, aliquoting, storage, and shipment.
  • • Defined ranges for processing times, temperatures, and storage conditions.
  • • Use of calibrated equipment and validated materials where applicable.
  • • Visual inspection and, where appropriate, pathologist review of samples.
  • • Deviations recorded, investigated, and communicated to sponsors.

Where study requirements demand, we work with sites to customize SOPs while preserving documentation and traceability, ensuring that bespoke workflows still remain quality-controlled.

Sample & Data Documentation Package

Each shipment is accompanied by a documentation package designed to support your internal QA and downstream analysis.

  • • Sample inventory with IDs, matrices, and storage conditions.
  • • Relevant clinical and pathological data fields, as agreed in advance.
  • • Shipping manifests and temperature log information where applicable.
  • • Copies of key approvals or certifications, if required by the study.

Biosafety, Handling & Logistics

We prioritize biosafety at every step, from sample collection environments to packaging and transport. Our aim is to protect both personnel and sample integrity.

  • • Use of appropriate PPE and biosafety practices at collection and processing sites.
  • • Validated primary and secondary packaging solutions for different matrices.
  • • Temperature-controlled logistics partners selected based on performance.
  • • Clear labelling, hazard communication, and documentation for all consignments.
  • • Incident and excursion reporting processes for any transport deviations.

Data Privacy & Confidentiality

Donor privacy and data security are integral to our operations. We limit access to identifiable information and ensure that only the minimum necessary data are shared for research.

  • • Use of coded identifiers instead of direct personal identifiers in research datasets.
  • • Role-based access controls for sensitive information at sites and central coordination.
  • • Secure data transfer channels and password-protected files where appropriate.
  • • Alignment with applicable data protection expectations in the jurisdictions we operate.

Need an Audit-Ready Biospecimen Partner?

Talk to our team about your protocol, regulatory expectations, and documentation needs. We will align a biospecimen strategy that supports both your science and your compliance obligations.

Discuss Your Requirements