Outsourced Pharma App Notes & Case Studies

  1. Automated pH Adjustment In An Intelligent Single-Use Mixing Platform

    Most pH adjustment process steps in single-use biomanufacturing require manual manipulation of the product and vessel, including off-line sampling, pH measurement, and the addition of acid and base.

  2. Sharing Instruments: Bottleneck Or Increasing Utilization?

    Development of efficient manufacturing processes is a necessity for cost-effective production of biopharmaceuticals. By carefully designing and evaluating your experiments, sufficient information for optimizing your process can be obtained with a minimal number of experiments.

  3. How A Big Pharma Company Quickly Transferred 2 Oral Powder Antibiotics To Another Facility

    Patheon’s Puerto Rico Operations specialize in the high volume commercial manufacture of solid dosage forms including tablets, capsules, and powders packaged in bottles.

  4. Sourcing For Savings Case Study

    To help the client overcome these challenges, inVentiv Health formed a strategic partnership with the biopharmaceutical company and took over responsibility for all of its trial-level clinical data management activities in the United States.

  5. Recruiting Patients With Impaired Renal Function Case Study

    According to FDA Draft Guidance published in March 2010, a pharmacokinetic (PK) study should be conducted in patients with impaired renal function when the drug is likely to be used in such patients and when renal impairment is likely to mechanistically alter the PK of the drug and/or its active metabolites.

  6. Phase II Alzheimer's Case Study

    A double-blind, Phase II, placebo-controlled clinical trial to evaluate the safety and efficacy of a novel compound in subjects with mild to moderate Alzheimer’s disease.

  7. Benefits Of Non-Clinical Scientific And Regulatory Support For Late Phase Studies

    This case study illustrates how robust non-clinical advice and consultancy can expedite and accelerate drug development and increase the likelihood of regulatory acceptance
    for development programs.

  8. Safety Expertise Leads To FDA Approval For Customer Compound

    inVentiv Health was providing a client with drug safety services for an oncology compound development.

  9. Non-Clinical And Regulatory Expertise Accelerate Development Into Phase II-III Clinical Studies

    The client needed assistance with the development of non-clinical program and regulatory documentation to support Phase II-III clinical trials in Europe (daily dosing for one year).

  10. Adverse Event Narrative Writing

    inVentiv Health was initially contracted to prepare approximately 210 serious adverse event narratives for a leading global biopharmaceutical company.