Biosimilars: A Global Investigator Survey

Biosimilar drug development has been a trending topic in the clinical research industry for some time, and we surveyed Investigators across the globe to capture their outlook on these programs.

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Webinar: The Evolution of Response Evaluation in Oncology Trials

Discover the history and evolution of response evaluation used in oncology trials during our webinar that you can view in our video library.

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Glioblastoma / Anaplastic Astrocytoma Case Study

Pharm-Olam is currently partnering with a sponsor company in the development of a treatment for Glioblastoma / Anaplastic Astrocytoma. This type of brain tumor has very few available therapies, so this study’s goal is to assist in potentially identifying additional effective treatment options.

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Regulation EU No 536/2014: What’s New and What’s Changed

The European Medicines Agency (EMA)'s Clinical Trial Regulation (EU No. 536/2014), which governs research of medicinal products for human use, is scheduled to go into effect in October 2018. According to the EMA's official website, the Regulation "aims to create an environment that is favorable to conducting clinical trials in the European Union (EU), with the highest standards of safety for participants." The objective is to apply a set of rules consistently throughout the member states in the EU. Review our six changes and updates that you need to know:

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Recruitment of Patients in a Phase III Systemic Lupus Erythematosus Study

During the planning of a Phase III Systemic Lupus Erythematosus (SLE) anti-B cell therapy, the Sponsor company called on Pharm-Olam to assist in the identification and enrollment of patients.

Discover the challenges Pharm-Olam encountered and the solutions implemented in this study.

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Webinar: The Do's and Don'ts of Study Transfer

Rescue Studies come in many forms — from assistance in patient recruitment to a complete takeover. We know how difficult it is to think of asking for clinical trial assistance, but Pharm-Olam has been contacted with increasing frequency to support ongoing studies. In an open forum, we will discuss our experience in over 75 rescue/supplementation studies and offer you lessons learned and some tips we’ve gathered along the way.

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Learn how to maximize the feasibility process

The clinical trial feasibility process is vital to the start-up process of a clinical trial. In this infographic, we present some tips to help you during this process.

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Antibiotics Drug Development Webinar

Antibiotic drug development is constantly changing and evolving with each new breakthrough driven by the urgency for new treatments. The scientific approaches used in development, along with the primary and secondary endpoints being used in research programs, are changing. This webinar will provide a high-level overview of the challenges to plan for during study design and will provide tips and suggestions on how to maximize your study’s effectiveness.

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Accuracy and Compliance in a Phase I/II Trial Involving Preterm Neonates

Pharm-Olam was contracted to provide clinical research services on a Phase I/II pediatric Respiratory Distress Syndrome study involving neonates with a gestational age between 27 and 33 weeks.

Discover the challenges Pharm-Olam encountered and the solutions implemented in this pediatric study.

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Predictive Resupply in Clinical Research: How to Cut Costs and Ensure Adherence to Study Protocols

In the floor-and-ceiling drug resupply method, an inventory management system restocks drugs up to a site’s storage capacity, or “ceiling” level, whenever it has been depleted to protocol minimums (the “floor” level). Typically, individual unblinded drug types (e.g., active and placebo) are counted separately for the floor level, and whenever either type reaches floor level, both types are restocked to ceiling level. In this whitepaper you will learn why the floor-and-ceiling method is not adequate for all studies and it will outline Pharm-Olam's 5-step algorithm that can cut costs and ensure adherence to study protocols.

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Quick Studies: Pharmacovigilance

Our Quick Study article series explores Pharm-Olam’s forward-thinking approach to risk-management, safety monitoring and analysis in drug development and post-marketing.

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11 Tips to Assist in Successful Orphan Drug Development

The prevalence of fast-track approvals, marketing exclusivity, tax credits and research subsidies has put the spotlight on orphan drug clinical trials. Detailed planning and timely execution of these trials are critical to the ultimate success of the product. These tips for successful orphan drug development have been collected from our work in ongoing and completed orphan drug trials.

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Whitepaper: Reconsidering India as a Clinical Trial Location

For many years, India's regulatory environment, coupled with concerns about start-up timelines, data quality and ethics, has made the country a less-than-attractive option for clinical trial sponsors. However, since 2014, authorities have been hard at work revising policies in the favor of clinical research. India's evolving clinical study environment is explored in a new whitepaper.

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13 Tips to Overcome Design & Operational Challenges in Biosimilar Clinical Development

The explosion of interest in biologic therapeutics, both in its potential cost benefits for patients and large growth potential, has created a significant buzz in the drug development industry. Since biosimilar development is still relatively new, there are still questions about how to properly run an effective and efficient clinical trial. The approval of the first Biosimilar in the United States created a blueprint for future submissions, but the evolving competitive and regulatory landscape makes it difficult to stay on top of development updates.

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Acute Bacterial Skin and Skin Structure Infection Case Study

To successfully manage an Acute Bacterial Skin and Skin Structure Infection (ABSSSI) study, Pharm-Olam provided a complete enrollment solution for the management and data submission of this multi-region study. With the increase of ABSSSI diagnoses and ABSSSI-related hospitalizations, inconsistent treatment methods for those diagnosed, and resistance to previous standards of care makes this an important study for those in need.

We delivered a total of 380 patients for this particular study within 9 months, which allowed for the study to be completed 2 months ahead of time.

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