The Clinical Trial Process Explained From Study Start To Closeout

[@INVICTUS9100]

I am new to clinical trials and this has really helped me. Thank you!

[@mgupta]

I'm a finance guy and I understood a lot of it. I have been googling acronyms etc so I had some foundational knowledge. This is my second year in biotech.

[@Kphyl]

Spot on. I've only just been working at IQVIA for about 1 year and I still feel like there are heappssss more to learn in the industry.

[@ParagTechVideos]

I am a recruiter for IMS Health for which position you are working on??

[@KalyaniMahajan111]

Hey can we directly join iqvia or TCS after the completion of course?​@@ParagTechVideos

[@vijayanirmale5636]

Hey Dan... thanks for guiding..you are superb...your teachings are so very clear and helpful 👍🏻👍🏻

[@LittleDeeAnnhertel]

I Love watching all of your videos!

[@dansfera]

DeeAnn Polacek thank you!

[@hyeryeonkim1578]

Thanks!! Your videos are very useful!! Keep uploading please🙏🙏

[@dansfera]

thanks!

[@irinasegovia4900]

Thank you for this video, very useful content. Keep up this good work!

[@dansfera]

I appreciate you very much

[@nmasinachicaliben3547]

What does a clinical data manager do from start to finish of a clinical trial. What is the difference between the role played by a clinical data manager and a clinical trial manager in a CRO.

[@dansfera]

Video soon

[@lorriebisesi9147]

Thank you for all the great information!

[@dansfera]

+Lorrie Bisesi thanks Lorrie!

[@roardinoson7]

I have an interview for a clinical trial co-op so this is helpful!

[@embracelifeTim]

Dan, this is great content I like what I've seen I'm sure we could have some very advantageous conversations

[@dansfera]

Anytime reach out

[@yves8436]

Thank you very much. Even as a drug development student I find this very useful!

[@nidhigupta84]

Thank you so much! very informational! Do you have any video for tasks and activities from sponsor side as well?

[@dansfera]

Coming soon!

[@susanromano5705]

Excellent overview Dan

[@JenniferJiang2013]

Can you do a video explaining how to determine maximum tolerated dosage for Phase I trials?

[@dansfera]

I may need to interview a dr for that one, will do!

[@spruceguitar]

You need to be a PI or a sub-I for that competency. If you are an MD in a CRO for example you will get that training from the PI. But you really need solid experience at least as a sub-I in order to responsibly negociate that Protocol / ICF component with a Sponsor, and know when not to accept a very high dose of a molecule that Sponsors want to test in phase I or an IP that should not be administered without a concomitant (which Sponsors in phase I will push for btw, and the PI needs to know when to say no) etc. But if you want to learn that competency from a video that explains it I would strongly discourage you to do so. You can’t buy experience. Lots of responsibility, because the safety of the entire study hangs in that PI decision and whether he is able to successfully negociate the Protocol with the Sponsor.

[@sushantsant8488]

Hello, this video is very good but, i also need to know about CRO in detail like all departments of CRO in detail.

[@NellyMandona]

thanks for this, you explain so simply yet professionally. what did you say about the medical liaison? the link between which two departments? thanks again

[@ShivaDev2399]

Sales and R&D side of pharma

[@oldsoulmillenial1134]

Hi dan, how can I contact you directly via phone to discuss arranging a personalized consultation?

[@sharonjones2775]

Can you do a video on counting, maintaining, and destruction of the IP?

[@dansfera]

I will do one with Monica on this

[@unbox2071]

Words come in real situations

[@saritajha652]

love this video

[@ramusunchu3211]

Hii

[@airkuna]

have anybody been in such trials??? have you ever had any bad or permanent side effect??

[@ms.apittman5557]

Thank you for sharing.

[@dansfera]

Thanks for listening

[@ronkeadesanya3013]

Does the site owner provide the subject for a study? Just want to understand. Thanks for you

[@dansfera]

Yes they’re responsible for recruitment

[@vishwaskatti3282]

What EDC tools you use to collect data

[@vaidyaayurvedaLife]

Hi there, how to run a trial for my product? It's a wellness product. Thank you.

[@dansfera]

Find regulatory consultant

[@patriciahaney3604]

Do you have a how to fill out or negotiate a CDA/NDA Agreement? What is considered standard language.

[@dansfera]

Will do

[@patriciahaney3604]

Thank you, Dan!

[@patriciahaney3604]

Thank you

[@2minuteschool929]

All were new at that time

[@janjoy9759]

Just got call from recruiter about Clinical QA manager position and they mention on the JD, that TMF experience required. I have 20 years experience in pharmaceuticals both commercial and clinical aspect, but primarily with deviations, CAPAs, SOPs, GMP training, and internal/external audits, a long with site wide metrics. Just trying to bridge my experience and see if my experience even relates somewhat with TMF. Is TMF completely different than what I mention in my experience? Just trying to prepare for upcoming interview Saturday. They seem real desperate to hire me and willing to pay high, but I dont want to set myself up for failure if i wont be able to do the work.... is it a Completely different animal? Any help greatly appreciated!!!

[@dansfera]

Where did you guys store records and documents

[@wiaslelmain3611]

Wisal elamin I need help becoming CRO

[@chetangupta5]

Awesome, indeed very useful, Thank you. :-)

[@triptiparab5738]

Hello Dan, Please share about artificial intelligence in clinical research And future

[@dansfera]

I have a few podcasts on that. Search my channel

[@anne7667]

I am new here. Please don’t use abbreviations. Thank you.

[@dansfera]

check the 4.5 hour video on my page and get the book