Research Compliance

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23 04, 2020

Case Report Form Repository for Clinical Trials

2020-04-23T14:36:32-04:00

Gathering and securing data throughout the lifecycle of a clinical trial is of utmost importance in order to preserve study integrity. To facilitate this collection of critical data, researchers need access to various case report forms. Luckily, many reputable institutions have created databases to address this specific need. We’ve compiled a comprehensive list of [...]

Case Report Form Repository for Clinical Trials2020-04-23T14:36:32-04:00
8 04, 2020

Clinical Trial Remote Monitoring and SOP Adjustments (2020)

2020-04-08T18:35:52-04:00

Today's crisis climate is creating a dichotomy in clinical research. On the one hand, researchers are experiencing major clinical research disruptions across the globe due to direct proximity to patients, priorities of healthcare workers, and a fragile overall healthcare ecosystem. As a result, sites are closing, medical facilities are enforcing access restrictions, and there [...]

Clinical Trial Remote Monitoring and SOP Adjustments (2020)2020-04-08T18:35:52-04:00
11 03, 2020

Download | Your eRegulatory Action Plan

2020-03-11T17:30:06-04:00

Free Download Your eRegulatory Action Plan Interactive guide on how to cultivate successful evaluation, selection and implementation of eRegulatory at your organization Download Action Plan What you will learn: Identify unique operational bottlenecks and organizational goals Select proper clinical software [...]

Download | Your eRegulatory Action Plan2020-03-11T17:30:06-04:00
18 02, 2020

How the MAGI eISF Reference Model Will Impact Your Work

2020-02-23T20:24:23-05:00

eISF Reference Model Overview You’ve likely heard that the MAGI Global eISF / eReg Binder Reference Model Version 0.9 is open and available for review. By now, you may be wondering what’s next for me and my organization? Our representative on the MAGI eISF Reference Model Steering Committee, Jordan Tapley, walks us through [...]

How the MAGI eISF Reference Model Will Impact Your Work2020-02-23T20:24:23-05:00
3 12, 2019

Five Capabilities You Need in an eTMF

2020-02-19T09:40:51-05:00

The modern Electronic Trial Master File (eTMF) is no longer merely a document repository, but an effective platform for accelerating your clinical trials, reducing compliance risks and ensuring real-time communication with research sites.    With clinical research complexity and workload on the rise, how is the eTMF changing and what should you be looking [...]

Five Capabilities You Need in an eTMF2020-02-19T09:40:51-05:00
29 08, 2019

eISF Clinical Software Systems – Replacing Clinical Trial Portals

2020-03-04T14:43:00-05:00

Imagine that for every television channel you want at your house - Travel Channel, HGTV, ESPN, NBC, CNN, Disney Channel, C-Span - you must have a separate cable line dug in your yard, gray box hanging from the side of your home, and unique receiver system plugged up to your television. Sounds like a [...]

eISF Clinical Software Systems – Replacing Clinical Trial Portals2020-03-04T14:43:00-05:00
27 03, 2019

ALCOA-C in Clinical Trial Electronic Document Management

2020-03-15T19:42:15-04:00

Good documentation is vital to good clinical research. As the saying goes, “If it isn’t documented, it doesn’t exist”. In fact, one of the most common inspection findings in investigator site inspections is the lack of reliable, accurate, and adequate source documentation. Failure to maintain adequate and accurate case histories that record all observations [...]

ALCOA-C in Clinical Trial Electronic Document Management2020-03-15T19:42:15-04:00
12 02, 2019

5 Key Advantages of eRegulatory

2019-08-02T15:45:49-04:00

Over 75% of clinical trial sites who have not yet adopted eRegulatory plan to do so in 2019. Why? In addition to growing industry pressure from sponsors who expect a digital site infrastructure, trial sites with eRegulatory platforms are introducing key advantages over those sites without eReg. What are those advantages? Download Five Key Benefits [...]

5 Key Advantages of eRegulatory2019-08-02T15:45:49-04:00
18 01, 2019

How Lauren Begnaud Transitioned 65 Sites to eRegulatory at US Oncology

2019-08-01T17:09:06-04:00

In this interview, we talked with Lauren Begnaud, Manager of Regulatory Affairs at the US Oncology Network, to discover how she successfully migrated 65 trial sites, 400 studies, and 2,000 Investigators and Support Staff to Florence eBinders for eRegulatory. Lauren has over 10 years of experience in the clinical research field and has successfully [...]

How Lauren Begnaud Transitioned 65 Sites to eRegulatory at US Oncology2019-08-01T17:09:06-04:00
19 12, 2018

Key Expectations of Clinical Trial Operations Leaders in 2019

2019-08-02T15:47:54-04:00

Today’s clinical trial operations leaders are in a challenging and expanding role. You are expected to increase study capacity, manage more complex trial protocols, accelerate study startup, and ensure timely sponsor collaboration - all while remaining hamstrung by limited resources, siloed data, stronger regulations, changing sponsor demands, and a growing site footprint. Clinical [...]

Key Expectations of Clinical Trial Operations Leaders in 20192019-08-02T15:47:54-04:00