Neftaly: Best Practices for Laboratory Involvement in Clinical Trials

Clinical laboratories play a crucial role in the success of clinical trials by ensuring the accuracy, reliability, and regulatory compliance of all data derived from biological samples. At Neftaly, we follow internationally recognized best practices to ensure our laboratory services contribute meaningfully and ethically to clinical research.

By aligning with Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and ISO standards, Neftaly supports sponsors, CROs, and investigators in achieving trustworthy results that stand up to scientific and regulatory scrutiny.

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???? Why Laboratory Involvement Matters in Clinical Trials

Laboratories:

• Provide essential data for safety and efficacy assessments
• Ensure biospecimen integrity
• Help meet regulatory submission requirements
• Contribute to participant safety monitoring
• Play a role in early detection of adverse events

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✅ Neftaly’s Best Practices for Laboratory Support in Clinical Trials

1. Early Involvement in Trial Planning

• Collaborate with trial sponsors and CROs during protocol development.
• Provide input on:
  • Sample volume requirements
  • Processing timelines
  • Analytical methods
  • Stability and transport conditions
• Ensure that lab services align with study endpoints and regulatory expectations.

2. Adherence to Protocol and SOPs

• Strict compliance with trial protocols and lab-specific SOPs.
• Review and validate all laboratory procedures before the trial begins.
• Handle protocol amendments promptly and train staff on all updates.

3. Sample Chain of Custody and Integrity

• Maintain secure and documented sample handling, from collection through storage and analysis.
• Use tamper-proof labeling, barcode systems, and LIMS to ensure full traceability.
• Monitor and document transport conditions, including time and temperature controls.

4. Use of Validated Methods and Equipment

• All tests are performed using validated, trial-approved methods.
• Instruments are routinely calibrated and maintained to guarantee accuracy and reproducibility.
• Regular quality checks ensure compliance with GLP and GCP standards.

5. Data Integrity and Regulatory Compliance

• Follow ALCOA+ principles to ensure data is Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available.
• Use electronic systems with audit trails and access controls.
• Ensure timely and accurate reporting of results to the study sponsor or database.

6. Staff Competency and Training

• All lab personnel involved in clinical trials receive:
  • GCP and protocol-specific training
  • Ongoing education on regulatory changes and trial procedures
• Regular assessments ensure continued competency and readiness.

7. Robust Quality Control and Assurance

• Employ internal and external quality controls for every assay.
• Participate in proficiency testing and inter-laboratory comparisons.
• Monitor and address any deviations, with immediate corrective and preventive actions (CAPA).

8. Timely Communication and Reporting

• Establish clear communication channels with trial stakeholders.
• Provide rapid, transparent reporting of results, abnormalities, or adverse event indicators.
• Attend regular study meetings and support regulatory audits and inspections.

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???? Compliance and Accreditation

Neftaly’s clinical trial laboratories operate in accordance with:

• ICH-GCP and GLP guidelines
• ISO/IEC 17025 and ISO 15189 standards
• Regulatory authority requirements (FDA, EMA, SAHPRA, etc.)
• Local and international ethical standards

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???? Neftaly’s Commitment to Trial Excellence

With decades of combined expertise, Neftaly ensures laboratory involvement that:

• Enhances study quality
• Reduces trial risks
• Accelerates timelines
• Builds confidence with sponsors, regulators, and patients