Polaris Compliance Consultants
Study Sites: Show 'Em Your QC
Polaris Compliance Consultants

How can you make your research site stand out so you win more studies? Show ‘em your QC! A reasonable set of Quality Control procedures will convince Sponsors/CROs your site can be counted on to produce reliable data. It shows that managing quality at your site is a continual process, and doesn’t wait for their monitors to arrive. Here's some advice to get started.

E-Labeling... And Then Some

Janssen Research and Development has developed iSTEP, an intelligent packaging system for Investigational Product. The package is scanned when it leaves the company and scanned when it’s dispensed to the participant. Once the IP reaches the research participant, a smartphone app determines when the blister pack is opened so site staff can monitor drug compliance. The app provides the participant with informational videos and reminders, messages of encouragement, and important notifications from site staff.

RBM on Trial
Clinical Trials

Four years ago we published an article describing ADAMON, a rigorous, multi-year study to compare the effectiveness of RBM to that of traditional monitoring. The study is now complete, and the results are in. After 156 GCP site audits -- 1/2 of the sites having received RBM, 1/2 having received traditional monitoring – ADAMON concluded that "the potential benefit of extensive on-site monitoring is small relative to overall finding rates." Lotsa stats available in the study report for you data hounds.

Gene Therapy Has a GMP Problem
NY Times

The disabled viruses needed to convey the good genes to cells that need them are complex, expensive, and sometimes completely unavailable.
FDA and 3-D Drug Manufacturing
3D printing offers a number of advantages over traditional batch methods of drug manufacturing. Spritam, the first 3D-printed drug, has already been approved. Here’s what FDA is considering and doing to prepare for this new manufacturing method.

EKG: Easy as ABC

Kardiaband, a new accessory for Apple Watch has been cleared by the FDA as a medical device. Pair it with an app on your smartphone and voila -- an EKG reading.

Polaris Compliance Consultants News

Polaris is pleased and proud to welcome Diane Tilley as our new Director of GCP. Diane has had a broad career working as a clinical research professional, a licensed attorney, and a certified Family Nurse Practitioner. She’s served as Director of QA for both large and small CROs, and also has experience working in the  university and private practice settings. With that resume, Diane had her choice of companies, so we’re really glad that she chose to come to Polaris and work with us and our clients.

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Older Posts

Love at First Site: Early Signs of Strong PI Oversight

Anticipating Tensions Between Clinical Care and Study Protocol

Coping with Scoping your CSV/Part 11 Audit

Notes 2 Fix Your Notes 2 File

When GCP and GMP Meet

Site Selection: Don't Forget About the Study Drug

When is a Customer NOT a Customer?

Avoiding Protocol Deviations

Outsourcing Options for Small Sponsors

FDA Site Inspections: 5 Tips for Success

A Musical Parody: She's More Than a Warehouse to Me

Movie Quotes for QA Professionals

SOP Revision, SWAT Style

Study Sites: Too Many Vendors, Too Little Time

A Musical Parody: the Sound of Compliance

Q&A SOPs for Research Sites

Big Changes for ICH GCP and EU Regs

The CAPA Detective

A Musical Parody: the Modern Risk-based Monitor

Remote SDV/SDR: Alternatives to Redact/Fax

How to Tip Off a GCP Auditor in 25 Words or Less

Regulatory Tools Go UFO: Useful, Free & Online

What Does Risk-based Monitoring Mean for QA Auditing?

Anatomy of a GMP Vendor Qualification Program

Is the SDV in RBM Misunderstood?

Results of First Ever REMOTE Clinical Trial

Questions All Auditors Should Ask: the Use and Misuse of Audit Checklists

On the Quality of Vendor/Supplier Audit Responses

The Plain Writing Act of 2010: Lessons for Industry

Risk-based Monitoring vs. Traditional Monitoring: the ADAMON Project

What if you Needed SOPs to Run your Household?

Key Points of FDA's Draft Guidance on Quality Agreements for Contract Manufacturers

Ignorance Isn't the Problem; Preconception Is

Who's Looking Out for the Investigator

What SOPs Do I Need As A Dietary Supplement Distributor?

Yes, SOPs are Hard to Write...It's Not Just You

Turning GMPs Into Marketing Advantage


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