FEATURED ARTICLES

What You Need To Know About FDA’s Clinical Outcome Assessment Compendium What You Need To Know About FDA's Clinical Outcome Assessment Compendium

One of the goals of CDER (The FDA’s Center for Drug Evaluation and Research) is to foster patient-focused drug development. As part of that effort, the agency has published a compendium of clinical outcome assessments (COAs) to promote the use of patient-focused outcome measurement in the drug development process.

  • Do Your Clinical Trial Participants Feel Like Valued Customers?
    Do Your Clinical Trial Participants Feel Like Valued Customers?

    According to Roslyn F. Schneider MD, MSc, Global Patient Affairs Lead at Pfizer, patients can often have a feeling of being powerless, and be left with the impression they are there to serve the drug development process, and not the other way around. “There are times when it seems we are asking patients for their opinions simply so we can paste them in a pre-defined place in an existing system,” she says. “That is not how a company should be treating one of its most critical stakeholders. As an industry we need to continue to find new ways to incorporate participant feedback in a way that is good for patients, their families, and caregivers. This will be beneficial for our companies and societies as a whole since all of these stakeholders are very closely aligned.”

  • Can You Guess What This Trial Is Using To Fight Obesity?
    Can You Guess What This Trial Is Using To Fight Obesity?

    A promising new diet may work wonders for helping individuals lose weight and fight obesity. The trial will involve taking fecal matter from the digestive tracts of healthy and thin humans, which would then be freeze-dried and put in a pill. Individuals in the study would then ingest the pills. The research does have some validity. Researchers at the Massachusetts General Hospital in Boston have discovered the microbes in digestive tracts of healthy individuals are different from those in obese individuals.

  • Speed, Savings And Security: Leveraging The Power Of E-Signatures In Clinical Trials
    Speed, Savings And Security: Leveraging The Power Of E-Signatures In Clinical Trials

    The devil is in the documentation. At least, so it seems with clinical trials. Every step, decision and result of each trial phase must be inked, approved, filed and submitted to appropriate parties. Because trials are part of drug and therapy development, keeping detailed records is a must. But the sheer amount of paper-pushing can dramatically slow the pace of a clinical trial.

More Featured Articles

WHITE PAPERS & CASE STUDIES

  • Phase I-IIA Clinical Trials Brochure

    At INC Research/inVentiv Health we have the ability to expedite clinical programs and build the foundation for continued development of the product.

  • Regulatory Approval Of Clinical Studies In The Netherlands

    The EU Clinical Trials Directive (CTD) has been fully implemented in the Netherlands. 

  • New Molecular Entities (NMEs) - The Path Of Resistance

    On a global scale, the number of new molecular entities (NMEs) in development—and, more importantly, the number being approved by regulatory authorities— has dropped significantly in recent years.

  • eTMF And The eClinical Universe

    How Electronic Trial Master Files (eTMFs) Work With Other eClinical Systems To Help You Meet Regulatory Requirements.

  • Signature Requirements For The eTMF

    Sponsors and CROs want to ensure that the processes and workflows they use in their electronic Trial Master Files (eTMF) comply with all regulatory requirements, resulting in a robust system that will produce complete documentation able to withstand an agency audit. To provide a solid basis for decision-making, we’ve researched both the regulatory basis for signatures and the technology implications around how to collect signatures. Since the goal of any eTMF system is to streamline processes and increase compliance, implementing valid signature processes in the least cumbersome manner is always of concern.

  • Strategic Clinical Outsourcing Considerations: The Interdependency Of Clinical Drivers

    A solid outsourcing strategy is critical to leading your organization to a successful outsourcing experience. Of course every organization in need of outsourced services must consider their priorities: Is it cost? Timelines? Team experience? Some combination? Inevitably the salient considerations are a combination of each of these factors, yet some will be weighed more heavily than others. By Kevin Boos, RDP Clinical Outsourcing, Scott Connor, Acurian, and Meenal Patel, RDP Clinical Outsourcing

More White Papers & Case Studies

SERVICES & PRODUCTS

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.

Biostatistical Services

Delivering high-quality and accurate data analysis, SynteractHCR is a contract research organization that provides robust and customized biostatistical services tailored to your study’s needs. At SynteractHCR, we believe that a statistician is a vital component in the clinical development process. Working as your partner, SynteractHCR’s expert biostatisticians will review your study’s needs and determine the best methods for collecting, analyzing and presenting your data, all in compliance with regulatory guidelines. Our team is trained to provide creative thinking and analysis optimized for your unique study designs. We provide access to your data in a format well-suited to your project requirements.

Phase IIb-III Clinical Trials

With decades of experience in clinical trial design, INC Research/inVentiv Health offers a full range of clinical trial services including bioanalysis, biostatistics, data management, feasibility studies, global safety and pharmacovigilance, medical writing, project management, protocol and case report form design, quality assurance, regulatory affairs, risk management, site management, strategic planning, and study monitoring.

Clinical Trial Feasibility

Delays in research have significant time and cost implications and negatively impact an organization, regardless of size or financial stability. The potential for delays can be decreased or mitigated through comprehensive planning.

Oncology Services
A leading western CRO in Russia, ClinStar offers invaluable experience to enhance your study execution, resulting in higher-quality results. We offer local regulatory, customs and logistical expertise, as well as clinical teams that are therapeutically trained in oncology.
CNS Services

A leading western CRO in Russia, ClinStar offers invaluable experience to enhance your study execution, resulting in higher-quality results. We offer local regulatory, customs and logistical expertise as well as clinical teams that are therapeutically trained in CNS diseases.

More Services & Products

NEWS

More News