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  • Survey: 50% Of Americans Not Aware Of Clinical Trials
    Survey: 50% Of Americans Not Aware Of Clinical Trials

    Patient recruitment remains a significant challenge for pharma companies conducting clinical trials. If all potential participants were aware of clinical trials, convincing patients to participate in them would still be a challenge. But that task becomes significantly more difficult when a large percentage of the population does not even know such trials exist.

  • Breakthrough Therapy Designation Helps Genentech Navigate Difficult Trials
    Breakthrough Therapy Designation Helps Genentech Navigate Difficult Trials

    FDA started the Breakthrough Therapy Designation program in 2012. Since then, Genentech has garnered 15 designations, more than any other company. Jeffrey Siegel has been an instrumental component of that success. Siegel is Genentech’s senior group medical director and spent 14 years with FDA prior to joining the company. He has spent most of his career in pharma developing products to address the unmet medical needs of patients. 

  • Clinical News Roundup: Why All The Love For Adaptive Trials?
    Clinical News Roundup: Why All The Love For Adaptive Trials?

    Clinical News Roundup for the week of April 10, 2017 with information on Scott Gottlieb and adaptive approaches, preparing for epidemic clinical trials, proposed tax law changes for clinical research, and using selfies to improve medicine adherence.  

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  • From Molecule To Market: Pharmaceutical Outsourcing Expertise

    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.

  • Full Contained Service Solution For Investigational And Commercial Products

    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.

  • Clinical Trial Supply Solutions

    Our comprehensive service offering includes early stage formulation and analytical development, API capsule and vial filling using Xcelodose® technology, scale-up and stability testing, process validation, technology transfer and all associated analytical support services.

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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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