Clinical Research Solutions
5 of the Most Common Biopharma Risks Today
Spending on prescription drugs in the United States is expected to reach $600 billion by 2023. The continuously increasing need for pharmaceuticals is mostly driven by an aging population, a rise in...
Clinical Research Solutions
A Guide to Clear-Cut Planning and Program Execution
The landscape of clinical trials and other clinical development projects has dramatically changed in recent years. Progress made in scientific discovery is paving the way to novel therapies and...
Clinical Research Solutions
5 Scenarios That Need a Clinical Operations Team
New drug development is a costly, lengthy and risky process. Hurdles spring up at every stage and today's landscape puts sponsors under more pressure than ever before. Clinical trials are becoming...
Clinical Research Solutions
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...
Clinical Research Solutions
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...
Clinical Research Solutions
Changes in Medical Device Regulatory Requirements in Europe (2021)
In May 2021, the new European regulations on medical devices (EU MDR) will take full effect. Organizations face a unique set of compliance challenges, mainly due to the numerous changes and additions...
Clinical Research Solutions
The Importance of the eCTD Structure for FDA Approval
The Importance of the eCTD To harmonize the process of regulatory reviews for global drug development, a unified structure was developed and implemented for electronic Common Technical Document...
Clinical Research Solutions
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...
Clinical Research Solutions
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....
Clinical Research Solutions
Pharmaceutical Consulting during Product & Business Development
Pharmaceutical Consulting during Product & Business Development: To stay competitive in the pharmaceutical field, pharmaceutical companies need to have access to legal, product and clinical...