Why healthcare IoT devices need data monitoring

Use of healthcare IoT devices for sensing patient vital signs  enables fast and cost-effective remote monitoring of patient safety and data quality – however the challenges start after collecting the data. Healthcare IoT for sensing patient state is not a panacea. Monitoring of data you collect in your clinical trial using healthcare IoT requires up-front […]

The 2 most common mistakes in Clinical Research Data Management

Another survey piece that David wrote about common mistakes in clinical data management and some basic controls to stay from the common issues. Use automated monitoring to empower people We are all human. As much as we would like to rely on technology to automate every sector of clinical trial research, we still need the […]

The best alternative to paper in medical device clinical trials

There is an urban legend that paper is cheaper than EDC $1000/subject for paper-based data management (the going rate in Israel)  is a lucrative business for small CROs, independent data managers and biostatisticians, but $1000/subject is not the same as “total cost of ownership” or TCO. The TCO of doing a clinical trial for an […]

Cost effective EDC for medical device clinical trials

There is a saying in American English dating back to the 1940’s – “Call me when you have a nickel in your pocket”. With limited budgets, small, innovative medical device vendors will be looking at the nickel in their pocket and thinking that they cannot afford a cloud EDC offering for clinical data management and opt […]

The key is not first to eSource, the key is smart to market

This post is not for the Pfizers, Novartis, Merck and GSK giants of the life science industry. Its for the innovators, the smaller, creative life science companies that are challenged by the costs, the regulatory load and complexity of executing a clinical trial. This post is dedicated to the startup entrepreneurs of the world. Building an EDC […]

Assuring patient compliance to the study protocol-spending smart on monitoring

Today I want to go beyond having compelling ideas, a team and a great market opportunity and talk about what you need to successfully execute a clinical trial on your way to FDA approval. Sometimes there is nothing more powerful than the passion and vision of an entrepreneur. But passion and vision are just not […]

Why paper should be your first choice for a medical device clinical trial

6 reasons to use paper in your clinical trial You’ve been considering cloud EDC for your next clinical trial, but you are put off by the perceived challenges and costs of implementation and operation. You shudder at the thought of DIY EDC solutions like Clincapture or Medrio and don’t have the budget for Medidata. For many […]

3 practical tips for cost-effective clinical monitoring

Originally posted by Jenya Konikov-Rozenman on May 31, 2016 in Clinical Trial Monitoring Can you use technology to reduce the costs of your clinical trial and shorten your time from study data lock to regulatory submission?  Jenya talks about how medtech developers can save money and reduce their time to market. If you are a medtech company […]

2 mistakes you do not want to make in your medical device clinical trial

Jenya Konikov-Rozenman Jenya is a co-founder and VP Clinical at Flaskdata.io. Jenya has a masters degree in biotechnology from the Hebrew University and is a doctoral candidate at Tel Aviv in medical science. She is GCP and CRA certified and leads FlaskData.io customer operations with super-human devotion to customer delivery. Jenya has 2 children – […]

Forging partnerships for high patient compliance

Clarifying ownership of patient compliance in medical device clinical trials requires building risk management into the operation and forging a good partnership between clinical operations, biostatistics and the clinical data management provider who can provide the technical infrastructure for calculating compliance indicators from the EDC, ePRO and connected medical devices in the study. Although this […]