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FEATURED ARTICLES

  • In Genome Editing Trials, The Effects Last A Lifetime
    In Genome Editing Trials, The Effects Last A Lifetime

    Sangamo Therapeutics is involved in the quickly growing field of genome editing, but with a twist. The biotech is currently recruiting patients for three rare disease clinical trials which will mark the first time a company performs genome editing in vivo. In a nutshell, the treatments will replace a patient’s defective or missing gene with a therapeutic gene that will be permanently stitched into the liver cells of the patient. 

  • Clinical News Roundup: China To Accept Foreign Clinical Trial Data
    Clinical News Roundup: China To Accept Foreign Clinical Trial Data

    Clinical News Roundup for the week of October 9, 2017 with information on China accepting foreign clinical trial data, Janssen launching iSTEP technology toolset for trials, FDA’s first Patient Engagement Advisory Committee Meeting, and CTTI issuing recommendations on investigator recruitment and retention.

  • Can We Improve On ClinicalTrials.gov?
    Can We Improve On ClinicalTrials.gov?

    Today, patients and pharma professionals looking for information on clinical trials generally visit ClinicalTrials.gov. On the site, users can search by condition/disease, country, and other keywords. Patients can find studies in which to participate, and researchers are able to find information on more than 250,000 studies being conducted in the U.S. and 200 other countries. But is it time for a new database that better meets the needs of pharma executives and researchers?

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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 INC Research/inVentiv Health, 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. INC Research/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.

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.

Medical & Regulatory Affairs Medical & Regulatory Affairs

Taking new products successfully through clinical development, submission and approval can be a difficult, expensive and lengthy process. SynteractHCR’s medical regulatory affairs group offers a wide range of services that spans the full range of product development, including training, performed by senior regulatory professionals with experience in pharmaceutical, diagnostic, device and biotechnology industries. Our medical regulatory affairs team is here to deliver on aggressive timelines and control costs, while ensuring compliance and patient safety.

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