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Medivdpharma
Comprehensive Pharmaceutical & Clinical Research
Services by Medivdpharma (MIP)
Medivdpharma (MIP) is a full-service, integrated biopharmaceutical partner providing end-to-end solutions in drug discovery, clinical development, regulatory affairs, and pharmacovigilance. We support the global pharmaceutical, healthcare, and biotech industries with a commitment to quality, ethics, and societal contribution.
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Expert on business transform dedicated to helping achieving long-term success and for sustainable growth with our business consulting.
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Reach worldwide
Our mission is our empower businesses off our all size too thrive in an businesse changing marketplaces. Our mission.
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Faster growth
Our mission is our empower businesses off our all size too thrive in an businesse changing marketplaces. Our mission.
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Awards archived
Our mission is our empower businesses off our all size too thrive in an businesse changing marketplaces. Our mission.
Comprehensive Solutions, Tailored for You
Quality Assurance (QA) & Auditing
Our QA auditors ensure the highest standards of compliance and data integrity across all operations.
- GCP/GLP Audits: In-process, retrospective, and system audits.
- Site & Sponsor Audits: Investigator Site, Sponsor, and Clinical/Analytical Laboratory Audits (per ISO 15189 & ISO 17025).
- System Audits: Computer Systems Validation, Database/Data Management, and Adverse Event Reporting.
- Documentation Support: SOP writing/review, archival audits, and final report audits.
We manage Phases II-IV clinical trials with a focus on ethics, quality, and confidentiality.
- Project Management: Planning, feasibility, patient access, recruitment/retention strategies.
- Site Management: Ethics committee submissions, clinical trial agreements, site selection, initiation, monitoring, and close-out.
- Monitoring Services: Pre-study visits, source data verification, query resolution, and adverse event management.
We handle data capture, processing, and reporting for both paper and electronic data capture (EDC) studies.
- Database Design: CRF design, annotation, validation programming, and user acceptance testing.
- Data Processing: Double data entry, discrepancy management, dictionary coding (MedDRA/WHODrug), and external data reconciliation (IVRS, labs, biomarkers).
- Compliance & Delivery: CDISC-compliant data transfers, database lock, and archival.
Our biometrics team ensures robust statistical analysis and reporting.
- Protocol Support: Sample size calculation, statistical input for protocols.
- Analysis & Reporting: Statistical Analysis Plan (SAP) development, SAS programming (SDTM/ADaM), Tables/Listings/Figures (TLFs), TRTD analysis, and interim/exploratory analyses.
We deliver high-quality, regulatory-compliant documentation.
- Study Documentation: Protocols, Investigator Brochures (IB), Clinical Study Reports (CSRs), patient information sheets, and informed consent forms.
- Publications & Abstracts: Manuscripts, posters, abstracts, and literature reviews.
- Quality Control: Medical query generation, medical monitoring, and quality control of deliverables.
We navigate complex regulatory pathways for seamless approvals.
- Clinical Trial Applications: CTA preparation/submission, regulatory authority liaison, CTRI registration.
- Pharma Submissions: Dossier development (CTD/e-CTD), DMF preparation, variation filings, CMC documentation.
- Licensing: Import/export licenses (DGFT), T-license procurement, GEAC approvals for biotech products.
We manage drug safety and post-marketing surveillance with precision.
- Adverse Event Management: SAE reporting, benefit-risk assessment, signal detection, and data mining.
- Case Processing: Medical review, narrative writing, CIOMS forms, and regulatory submissions.
- Post-Marketing Services: Aggregate report writing, periodic safety updates, and 24/7 medical consulting.
Why Choose MIP?
- End-to-End Expertise: From discovery to post-marketing, we provide integrated solutions.
- Regulatory Excellence: Deep experience with global standards (FDA, EMA, etc.) and local requirements.
- Quality-Driven: Rigorous QA processes ensure compliance and data integrity.
- Patient-Centric: Ethical trials and safety monitoring prioritize patient well-being.
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