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Overcoming Practical Challenges in Agile Projects

Overcoming Practical Challenges in Agile Projects

Agile is all the rage, and many organizations are tempted to implement Agile in their projects without fully understanding what types of projects work best, what the Agile methodology can support, an...

Migrating Seamlessly with new DIA eTMF Exchange Mechanism Standard (Part 1)

Migrating Seamlessly with new DIA eTMF Exchange Mechanism Standard (Part 1)

Traditionally, a trial master file (TMF) has been thought of as a collection of documents to be collated to satisfy the regulatory requirements of a clinical study. While this is still the case, today...

SEND has arrived. Are you ready?

SEND has arrived. Are you ready?

The pharmaceutical industry is undergoing a huge transformation. The traditional ways of clinical research will soon be a thing of the past, with disruptive technologies like machine learning (ML), ar...

Winning in the Next Technology Wave: Digitalization in Clinical Trials

Winning in the Next Technology Wave: Digitalization in Clinical Trials

The life sciences industry today is undergoing a wave of disruption, with biopharmaceutical companies embracing potential new ways to deliver a value-based model over volume by developing specialty pr...

The Journey to EU MDR/ IVDR Compliance: Key Lessons and Considerations

The Journey to EU MDR/ IVDR Compliance: Key Lessons and Considerations

The journey so far Year 2017 was a learning phase for the Medical Device industry. With the official launch of the European Medical Device Regulations (EU MDR 2017/745) and European In-Vitro Diagnosti...

Syntel’s Prescription for Life Sciences Document Management and Regulatory Compliance

Syntel’s Prescription for Life Sciences Document Management and Regulatory Compliance

Although high-profile data breaches grab the headlines, behind the scenes, life sciences is just as information sensitive as any industry. Any pharma company faces a major challenge when it comes to c...

Have the answers ready before you face a TMF audit or inspection

Have the answers ready before you face a TMF audit or inspection

TMF practices have matured considerably, and are now recognized as a critical step in the drug development cycle. However, a number of challenges persist. One key issue facing the entire life sciences...

Is Artificial Intelligence (AI) and Machine Learning (ML) the Future of Merchandizing?

Is Artificial Intelligence (AI) and Machine Learning (ML) the Future of Merchandizing?

The 2001 French romantic comedy Amelie told the story of a shy waitress who decides to change the lives of those around her for the better, while struggling with her own isolation.The painting below...

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