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Do You Need a Project Management Office (PMO)?

There is more to a project management office than managing projects. In fact, the project management office (PMO) acts as both a watchtower and a lighthouse to guide strategic initiatives toward success and maintain work standards to complete projects.    In The State of the PMO 2016, surveyed executive leaders confessed only 60% of their…

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7 Medical Writing Tips for the Oncology Field

In the wake of the 21st Century Cures Act (December 2016), the FDA has switched gears to accelerate the development of novel therapies and speed up the review process, particularly in the field of cancer research and treatment with the Oncology Center of Excellence. These efforts are the result of growing concerns over the progression…

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Everything You Need to Know About Rare Disease Day

There are 6,000 known rare diseases affecting more than 300 million persons worldwide. Over the past decade, those rare conditions – most often with a genetic basis and life-threatening outcomes – have become a matter of public health concern. In an effort to motivate and encourage progress in finding therapies and programs to support patients…

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EU Regulatory Changes for Medical Devices in 2020: Are You Prepared?

In May 2020, the new European regulations on medical devices (EUMDR) will take full effect.  Organizations face a unique set of compliance challenges, mainly due to the numerous changes and additions to the Medical Device Regulation compared to its Medical Device Directive predecessor. For the record, the complete document is nearly 3 times longer. What…

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The Importance of the eCTD Structure for FDA Approval

To harmonize the process of regulatory reviews for global drug development, a unified structure was developed and implemented for electronic Common Technical Document (eCTD) submissions. The structure is based on the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines.    The Food and Drug Administration (FDA) encourages the use…

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Medical Writing Lean Overview

When applied rigorously and comprehensively, lean principles can reduce organizational costs while increasing productivity and strengthening the overall quality of submissions What is “Lean” as it Applies to Medical Writing? Lean medical writing emphasizes the use of precision in organizing large volumes of data, with a focus on targeted data analysis and presentation. Central themes…

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6 Unique Challenges Hindering Oncology Clinical Trials

The research for cancer treatment is moving forward at a rapid pace. We’re witnessing a shift from chemotherapy protocols to MTAs (molecularly targeted agents) for immunotherapies in particular. Despite the promising advances and the positive results of such products currently on the market, many oncology clinical trials fail, often at the early stages.   A…

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Treximo 5 reasons projects fail

5 Reasons Projects Fail & How to Prevent Them

  Leadership at drug and device companies is continually overwhelmed with the constant balance of driving daily work, managing resources, and addressing unplanned emergencies. This balance is then tested when leadership is tasked with implementing a number of yearly special projects. These projects often address process, strategic, technical, or regulatory requirements that must be addressed…

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Pharmaceutical Consulting Treximo

Pharmaceutical Consulting during Product & Business Development

  To stay competitive in the pharmaceutical field, pharmaceutical companies need to have access to legal, product and clinical development, business strategy, and human resources experts. Startups can’t employ professionals specializing in all these areas, and it can even be a challenge for established corporations, especially in the case of hyper-specific issues.  Pharmaceutical consulting can…

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Medical Writing Mistakes

9 Medical Writing Mistakes to Avoid

With around 2.5 million scientific papers published every year, it is impossible for medical professionals to keep up with all the latest research. Every piece of content is fighting for eyes. To make sure your text gets seen in the crowd, you must create worthy content, target your audience, and avoid these medical writing mistakes.

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