Life Sciences

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...

Reduce Costs and Time Invested in Clinical Trials with Real-time Feedback

Reduce Costs and Time Invested in Clinical Trials with Real-time Feedback

Pharmaceutical companies are often among the largest and most complicated organizations in the private sector, which are constantly under close scrutiny and subject to complex regulation. Their busine...

Syntel’s Prescription for Automating Pharmacovigilance Adverse Events Management

Syntel’s Prescription for Automating Pharmacovigilance Adverse Events Management

It’s no secret that drug and device safety is of the utmost importance in today’s competitive life sciences marketplace, and Pharmacovigilance (PV) is a major component of an effective drug regula...