Study Source One
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Study Source One
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  • About
  • Contact Us

At Study Source One, our mission is to empower clinical researchers by alleviating administrative burdens and providing consultation services and support, allowing them to concentrate on what matters most:

 safeguarding their subjects and ensuring high-quality data. 

ABOUT

We recognize the complexities that clinical researchers face in the timely and costly creation of source and SOPs. Drawing on over 25 years of industry experience, we identified a critical need for a more efficient, streamlined approach to mitigate the time-consuming and challenging process of re-creating source study after study. In response to this challenge, Study Source One is committed to transforming the operational framework of clinical research, driving greater efficiency and productivity for the research site, whose primary focus should be subject safety and quality data.


Beyond our comprehensive document solutions, we offer specialized consulting services designed to address the unique challenges of clinical research. Our tailored approach ensures that our offerings are aligned with the needs suited to your individual site. Whether you need research questions or concerns addressed, training sessions, an assessment of your site processes to improve efficiency and ensure regulatory compliance, we are here to assist and support you. 

Melanie Gibb, ACRP-CP

  

Melanie Gibb has a vast amount of experience working in the Clinical Research Industry for 23 years as a Coordinator (7 yrs), Coordinator Manager (1 yr) and Site Director (15 yrs). Her career experience includes conducting, directing, and overseeing more than 200 phase I-IV clinical trials, throughout a broad spectrum of multi-specialty therapeutic indications from infants to seniors. Melanie is well versed with the Code of Federal Regulations Title 21 Part 312, all versions of ICH E6 Guidelines, FDA Guidance Documents, IRB’s policies and procedures, and Regulatory requirements. As a Site Director, she built a highly successful research department from the ground-up at a multi-specialty clinic with more than 150 Providers. One of her passions is helping others, which includes consulting, training, and mentoring researchers because the work they do is so important to our global community. 


We are here to help



Contact us today to learn more about how our services can benefit your site, assist you with challenges, and alleviate your research burdens



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