Sharepoint Solutions

Premier Research was given a tight timeline of less than four months from delivery of the final protocol to first patient in. With proper site selection to accommodate the needs of a fast start-up along with open and frequent communication with the principle investigator and the project team, they were able to meet this timeline.

Consistent management and communication are the keys to success when managing the supply chain of any advanced therapy clinical trial. In this article, we’ll review two case studies that demonstrate the importance of supply chain management by focusing on scaling up for commercial distribution and on packaging challenges within a cryogenic environment.

Airflow visualization testing, conducted as part of a routine review program, can help assure that aseptic filling areas remain under a state of proper control.

Submission of PADERs to the FDA is required during post-marketing drug safety surveillance. Instill confidence in your results and regulatory submissions by partnering with an experienced partner.

With the rise of eCommerce and mobile payments, gateways play an increasingly important role in the payments ecosystem. Unlike the simple payment gateways of a decade ago, modern gateways are increasingly diverse, and offer features and value-added services for merchants of all kinds.

The marketplace for orphan drugs is growing, and changes in the regulatory landscape are providing favorable conditions for collaboration in the area of drug development in rare diseases. Understanding the regulatory and operational nuances of orphan drug development can help sponsors position their promising compounds for clinical and commercial success.

As I was going through the metal detector at the airport, I tossed my pager in the bin. The security official looked at me and said, “You work in healthcare, don’t you?” I asked, “Why do you say that?” She said, “No one else uses pagers except for people in healthcare.” Her comment struck me; I thought, Wow. She is totally right.

This paper isolates three specific areas that warrant close attention for app developers, clinical trials sponsors and CROs designing trials powered with mHealth app tools: technology considerations, data considerations and regulatory considerations. These areas are vital to developing a compliant trial that generates meaningful data for clinical development using mHealth sources.

Truck Country evolves from MFP-based document capture to a tightly integrated digital document management solution featuring Alaris Scanners in 20+ remote locations.

School bus service contractors are responsible for getting students to and from school safely and soundly. Besides picking up and dropping off students at designated stops along the bus route, school bus operators are also responsible for inspecting their vehicles before each journey to ensure the safety of passengers, pedestrians, and other drivers on the road. For an operator of a large fleet of school buses, manually inspecting each bus used to be a time-consuming and labor-intensive affair.

A top ten mortgage lender in the United States has been providing loans across the country for nearly 40 years. In an effort to speed and simplify the loan approval process, a practice that is traditionally long and cumbersome, the mortgage provider enlisted mobile technology to allow for self-service automation. With the customer in control and able to provide information at their convenience, the loan process is shortened and simplified, allowing the organization to serve more customers than if they were to utilize only traditional processing methods.

The objective of this study was to develop and support a process for assessing the comparability of data used in global clinical trials from four individual laboratories, wholly owned by the same central laboratory entity, and that the same tests on the same samples are under statistical control and acceptable limits of variation.