Advanced Research Solutions by an expert with over 30 years of experience in biotech, specializing in Human Subject Research and working alongside Clinical Research Coordinators to ensure compliance with ICH GCP E6 R3 standards, making it a reliable choice for investors.
Not everyone within the clinical research enterprise understands the principals of human subject research. We are here to provide you and your team with information on these regulations and documents:
The protocol document must explain the science of the research to substantiate requirements to FDA . Protocols are often written with copy and paste from previously approved protocols. Often the language used or instructions given are inconsistent throughout. These confusions lead to study staff not understanding or confused with protocol assessments. We assist with reviewing you protocol, pointing out anything that could be misunderstood or is inconsistent. Simplification and harmonization will go towards meeting enrollment goals, plus keeping the research sites updated through the lifetime of the protocol.
Scientific and medical language can sometimes lead to confusion among enrolled participants. Coastal helps translate complex language into clear, practical, and concise language to ensure consent is voluntary and study procedures clearly outlined. Coastal has experience in taking confusing medical jargon and simplifying the language and layout using Health Literacy guidance. Using plain language significantly increases the likelihood that patients understand clearly the responsibilities of the research participant, ensuring fully obtained, autonomous, and documented informed consent.
We assist in preparing presentations for Investigator Meetings and Site Initiation Visits that are tailored to the needs of different audiences.
Coastal assist with making the outline or be there to assist your individual needs.
Joy is an expert in clinical research and an exceptional career mentor.
She guided me through challenging professional ethical issues with kind insight, care, and precision, helping me gain clarity and confidence in my decisions. Her wealth of knowledge and diverse professional background enabled us to analyze my situation from multiple angles and craft a strategic, values-aligned path forward.
To whom it may concern,
Joy Jurnack has been an exceptional mentor who played a crucial role in helping me navigate the clinical research space. Her deep knowledge of clinical research processes, regulations, and real-world application made complex concepts approachable and practical.
Joy was always supportive, approachable, and generous with her time. She provided clear guidance, thoughtful feedback, and consistent encouragement, which helped me build confidence and competence in the field. Her mentorship went beyond technical skills-she emphasized integrity, attention to detail, and critical thinking, all of which are essential in clinical research.
Thanks to Joy’s guidance, I developed a stronger understanding of research workflows, collaboration within multidisciplinary teams, and the importance of maintaining high ethical and scientific standards. Her leadership and dedication to mentorship have had a lasting impact on my professional growth, and I highly recommend Joy Jurnack as a mentor to anyone pursuing a career in clinical research.
Thank you
Dear Joy,
Thank you so much for taking the time to speak with me and share your guidance on navigating the transition from a non-clinical background into a clinical role. I truly appreciate your insights and your willingness to connect me with someone currently working in the field.
Thank you again for your time and generosity — it was incredibly helpful.
Sincerely,
A grateful mentee
I want to thank Brandon Barnes for assistance developing this website.
Thanks Brandon!