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FEATURED ARTICLES

  • Janssen’s Encouraging HIV Vaccine Trial Results
    Janssen’s Encouraging HIV Vaccine Trial Results

    Johnson & Johnson announced encouraging clinical data from a first-in-human study for an investigational HIV-1 vaccine regimen. The vaccine regimen, in development at Janssen Pharmaceutical Companies, appeared to be well-tolerated by subjects and elicited HIV-1 antibody responses in 100 percent of the participants.

  • Analgesic Trials: Improving The Quality Of Patient-Reported Outcomes With Central Rating Review Part 2
    Analgesic Trials: Improving The Quality Of Patient-Reported Outcomes With Central Rating Review Part 2

    One of the factors contributing to the risk for sponsor companies in analgesic trials is the difficulty in measuring the severity of pain symptoms during trials in a valid and reliable way. The experience of pain is, of course, subjective and is more receptive to placebo response than any other symptom (Gracely, 2009; Berthelot, 2011). Meanwhile, the scientific community has conflicting views on the validity and reliability of Patient-Reported Outcome (PRO) assessments gathered directly from patients. Read how sponsors can ensure that PRO assessments are scientifically sound and will support evidence requirements for marketing approval and reimbursement. Part two of a two part series.

  • Analgesic Trials: Improving The Quality Of Patient-Reported Outcomes With Central Rating Review
    Analgesic Trials: Improving The Quality Of Patient-Reported Outcomes With Central Rating Review

    One of the factors contributing to the risk for sponsor companies in analgesic trials is the difficulty in measuring the severity of pain symptoms during trials in a valid and reliable way. The experience of pain is, of course, subjective and is more receptive to placebo response than any other symptom (Gracely, 2009; Berthelot, 2011). Meanwhile, the scientific community has conflicting views on the validity and reliability of Patient-Reported Outcome (PRO) assessments gathered directly from patients. Read how sponsors can ensure that PRO assessments are scientifically sound and will support evidence requirements for marketing approval and reimbursement. Part one of a two part series.

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WHITE PAPERS AND CASE STUDIES

  • FDA Expectations For Diversity Inclusion In Clinical Research
    FDA Expectations For Diversity Inclusion In Clinical Research

    FDA recently released a snapshot report showing the diversity of clinical trial participants in studies conducted in 2015 and 2016. Out of over 31,000 patients who participated in clinical trials for novel products in 2016, 48% of the study participants were women, which was an increase from 40% in 2015. An increase in clinical trial participation of African Americans was also observed from 2015 to 2016 (i.e., 5% in 2015 vs. 7% in 2016). However, Asian subject participation in clinical studies decreased 1% between 2015 and 2016 (from 12% to 11%, respectively). Overall, the trend towards increasing the diversity of clinical trial participants is encouraging, but a continued effort is needed to keep moving in the right direction.

  • PCI General Brochure

    PCI is an integrated full service provider and a trusted partner to leading companies in the global healthcare industry; we offer unparalleled expertise and experience in taking compounds from the earliest stages of development through to commercial launch, delivering speed to market and commercial success for our customers. Core services include: Analytical services, formulation development, clinical trial supply, commercial manufacturing and packaging, QP services, supply chain management, storage and distribution.

  • PCI Contained Brochure

    Through the acquisition of Penn Pharma, PCI has significant experience in providing integrated drug development, clinical trial supply and manufacturing of solid dose potent products to high standards of safety and quality.

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SERVICES AND PRODUCTS

Clinical Trials Feasibility And Clinical Informatics Services Clinical Trials Feasibility And Clinical Informatics Services

At inVentiv, our ultimate goal is to improve the planning and execution of clinical trials in a cost-effective and timely manner.

Rare Disease And Orphan Drug Research Rare Disease And Orphan Drug Research

While developing drugs to treat rare diseases is more viable from a business perspective than ever before, the clinical research and go-to-market planning process is still fraught with challenges. Regulations, protocols, logistics, and reporting are all different when patients are scarce, the stakes are high, and treatments are complex.

Autoimmune Disease Research Autoimmune Disease Research

Autoimmune disease covers a wide spectrum of unmet medical needs. For example, in Lupus, physicians use a wide variety of medicines to treat the underlying disease, but the remaining unmet medical need is high. In Rheumatoid Arthritis, there are many treatment choices available to patients and, therefore, optimal treatment is individualized.

Chronic Obstructive Pulmonary Disease (COPD) Research Chronic Obstructive Pulmonary Disease (COPD) Research

Respiratory studies—particularly those for COPD—pose extraordinary logistical and clinical challenges for sponsors. inVentiv Health, having extensive experience in conducting COPD trials, has developed unique ways to overcome these challenges. We combine novel recruitment and retention strategies with innovations in study design to reduce risks and ensure that COPD trials complete on time and produce high quality data.

NDA Approval And Post Approval Services NDA Approval And Post Approval Services

From 2006 through 2015, Patheon helped clients earn 92 NDA approvals. That’s  twice as many as any other CMO. Success brings more success at this stage. That’s because depth of experience, reliability of quality and refinement of processes are all important in the final push for regulatory approval and making the transition to commercial manufacturing.

Clinical Operations Clinical Operations

Clinical operations are a critical component in all studies. SynteractHCR’s highly skilled staff is well-versed in clinical trial operations including implementing, monitoring and managing the clinical components of a study. From start-up to close-out, experienced clinical managers and clinical research associates (CRAs) oversee each study’s clinical processes to ensure proper planning, conduct, patient safety, and data quality, while fostering good communication between study sites and sponsor.

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