Ann Conner

Ann Conner
Ann is the President of Harbor Clinical.
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Recent Posts

7 Tips for Enhancing Medical Writing Quality and Efficiency

Posted by Ann Conner on Jul 28, 2020 2:47:33 PM

As sponsors continue to restart paused studies, there will be a flurry of medical writing activities taking place to support IND submissions, investigator brochures, protocols, and other documents. Given that, below are tips to help improve the quality and efficiency in creating these documents.

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Topics: clinical trial, fda, Clinical Research, Biotech, Pharmaceuticals, biotechnology, medical writing

Vacation Planning in 2020

Posted by Ann Conner on Jul 14, 2020 8:04:00 AM

by Larry Claflin Jr.

Planning a vacation in the middle of a global pandemic with limited travel options?

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Topics: Clinical Research, Pharmaceuticals, biotechnology, vacations

Improving Edit Check Programming: a New Metric

Posted by Ann Conner on Jul 9, 2020 5:27:39 PM

Edit check programming and testing is time consuming and labor intensive. As such, it is efficient to minimize the time spent on programming by getting it right the first time. Historically, data management have measured edit check success as the percentage of edit checks that pass User Acceptance Testing (UAT). However, that may not be the best measure. What if an alternative metric leveraging Lean Six Sigma Methodology was used? The Rolled Throughput Yield (RTY) is a metric often employed in manufacturing operations to detect the probability that a process with more than one step will produce a defect free unit. If we track this metric for the edit check process, we can better gauge the probability of success of the edit check program.

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Topics: clinical trial consulting, Data Management, Database Development, Clinical Research, Biotech

Vendor Oversight: Not a New Normal, Just an Interim Normal

Posted by Ann Conner on Jun 23, 2020 9:20:16 AM

Given our recently-modified approach to executing clinical trials due to the COVID-19 pandemic, it is critical that we update our vendor oversight approach, ask key questions of our vendors, and modify our strategy based on the answers to these questions. Harbor Clinical has the experience, expertise, and plan to assist you in adapting your vendor oversight quickly and effectively.

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Topics: clinical trial strategic planning, clinical trial consulting, fda, inspection readiness, clinical trial inspection

Inspection Readiness - A Critical Success Factor in Clinical Trials.

Posted by Ann Conner on May 14, 2020 6:45:30 PM

A consistent challenge in conducting clinical trials of new pharmaceutical products is staying in compliance with governmental requirements. Governmental organizations such as the FDA in the United States conduct inspections with the purpose of verifying that the clinical trial is adhering to the requirements and standards in force. The FDA, for example, will conduct inspections for the one or more of the following reasons:

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Topics: clinical trial strategic planning, clinical trial consulting, fda, inspection readiness, clinical trial inspection

Remote Services Capabilities

Posted by Ann Conner on Mar 12, 2020 11:22:10 AM

The expanding Coronavirus (COVID-19) global crisis has governments, companies and people implementing plans to respond, meanwhile, governments and businesses still must run, and people still need to lead their lives.  At Harbor Clinical, we’re prepared for events like this by having effective plans to work remotely in place. 

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Topics: clinical trial strategic planning, clinical trial consulting, clinical trial remote services

Strategic Clinical Trial Planning

Posted by Ann Conner on Feb 20, 2020 3:48:27 PM

At Harbor Clinical, we provide expertise to small/mid-sized biotech/pharma companies   to ensure the best possible outcomes of the clinical trials that are  crucial to their company’s success.  We provide subject matter experts across functional areas including quality assurance, vendor oversight, clinical operations, medical writing, regulatory, biometrics and strategic development. 

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Topics: clinical trial, clinical trial strategic planning, strategic planning, clinical trial consulting

Learn More From Us

We’re committed to quality and committed to meeting or exceeding your expectations.

Established to be your integrated Quality Assurance and Regulatory Compliance partner, with a laser focus on facilitating your clinical trial execution. Developing and supporting your quality initiatives from Day 1, the Harbor team is committed to quality through each functional service we provide.

We provide a hybrid of services which ensure all aspects of clinical trials meet quality assurance and regulatory standards – from study documentation, vendor oversight, and flexible resourcing throughout operations.

Watch our blog for articles that help you get the most from your clinical trials.

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