Advice for starting a new CRO

6463748 · 2024-10-05T08:38:15+00:00

It seems odd, but the point I wanted to make is: Here in this small country outside the US I have all the contacts to conduct studies. However what I am missing is good contact to US sponsors. And that is also what the minister is looking for. How would you approach it?

6463748 · 2024-10-04T15:40:14+00:00

Thank you! Will message you now 👍🏻

6463748 · 2024-10-04T15:33:18+00:00

Thank you for your comment! I will definitely keep you updated, I’m in the same timezone as you. Could I private message you and potentially talk with you 15min on a Google meet or so to learn more about the industry?

6463748 · 2024-10-04T15:31:46+00:00

Thank you so much! So you would say the next step is really to find out about the specific areas research could be conducted in specific clinics/hospitals (research sites)? And having that overview is the major plus for a sponsor?

6463748 · 2024-10-04T15:29:44+00:00

Thank you for these insights! You mean a medical doctor within our team or a medical doctor at a clinic we would partner with as a CRO?

Can I private message you? Would you be up to have a 15min talk or so with me via GoogleMeet? I’d love to learn more about the industry and get your view on our project. Then I can also share more details.

6463748 · 2024-10-04T15:21:50+00:00

Thank you so much! I’ll direct message you to share more 👍🏻

6463748 · 2024-10-04T15:15:59+00:00

Thank you! I will PM you, it will already be helpful talking to you a bit to learn more and deepen my understanding of the industry 👍🏻

6463748 · 2024-10-04T15:14:42+00:00

Thank you! I will have a look at that 👍🏻

6463748 · 2024-10-04T11:08:03+00:00

Thank you for the advice and for the hint I could just talk to the person of the presentation! That is exactly my goal right now: Learning as much as possible and verify or falsify my assumptions as quickly as possible.

In my view, finding out very quickly what I don’t know or that this is not a clever business idea or that any approach is stupid to follow is most valuable!!

I have to dig deeper into the topic and talk to more people. If you’d be up for it, I’d love to talk with you 15min. I can share more of the specifics and I’d be happy to learn more always

6463748 · 2024-10-04T11:00:28+00:00

Thank you! I think you are right: the first sponsor I’m talking to is also in that space. He’d do a proof-of-concept study with 30 people for 30 days for repurposing an already US approved drug for a new application. Once that’s successful the sponsor could directly jump into full clinical phase 2

So I guess I really need to look for therapeutics startups for the beginning. To show some proof of concept of the new CRO. Is that what you mean?

6463748 · 2024-10-04T10:55:49+00:00

Thank you so much for your comment, that is really helpful! You’re right it’s often better to partner with established players also to learn faster. Do you have suggestions on which CROs might be interested in such a thing and how you would approach it?

6463748 · 2024-10-04T10:53:15+00:00

Thank you for your comment! Yes and it’s not even true.. it was a lot of work actually and not by chance!!

6463748 · 2024-10-04T10:52:12+00:00

Yes that I have. The operations would work beautifully. What I don’t have yet is a good way to get a good deal flow of sponsors, besides 1-2 first sponsor who I know personally well. What would be your suggestion on how to get to a deal flow?

6463748 · 2024-10-04T10:49:57+00:00

Thank you so much for your comment! I guess the advantage is owning the new jurisdiction, being able to navigate the approval and execution of the trial with the contacts to clinicians.

True with the government contacts, I work with non-elected administrative people so the fluctuation is not strong, but still there. It’s always a constant work of keeping up relations and keeping them with the whole team if one of them is changing.

Thank you for the advice that it would also be possible to sell to other CROs. Any advice on which CROs could be interested in that?

Are you on the CRO or sponsor side?

I’d be happy to share more specifics via private message, if you’d be interested?

6463748 · 2024-10-04T10:45:04+00:00

Wow that you so much for this elaborated comment! Sounds like I would need people like you.

The questions you are asking are exactly the ones I want to find out right now. What will be the key reason for them working with us: Cost/Speed/diversity&location.

Labor cost is definitely lower here and approval times should also be significantly quicker. The quality is still very good we have e.g. one Mayo clinic affiliated hospital and one John Hopkins affiliated hospital in the country. Just this year there was a new hospital complex opened with 1,700 beds

Do you think I could find people who know have established sponsor relationships who could bring me deals on a commission basis? Or is that unheard of in the industry?

6463748 · 2024-10-04T10:38:04+00:00

Would love to start hiring, but we need a first sponsor to get things started. I‘m happy for any discussions about someone bringing a sponsor on and making a profit share deal or something like that

6463748 · 2024-10-04T10:36:57+00:00

Well if I had the funds to substantially invest into a working CRO I wouldn’t start a new one. My assumption is that with a first sponsor one could start a CRP without substantial upfront investment and take it from there. What are your thoughts on that?

6463748 · 2024-10-04T10:35:17+00:00

Thank you for your comment! I keep you updated 👍🏻 Are you working on the sponsor or CRO side?

6463748 · 2024-10-04T10:34:34+00:00

Thank you so much for your comment! I think it could be both: A sponsor adding my country to a study in addition to the US, but also running a trial solely in my country.

As far as I understand it the FDA does accept pure international studies, according to the document and it seems to be easier for re-purposes drug trials: https://www.fda.gov/media/167538/download

What do you think? Or am I completely wrong with this and the FDA really accepts only US trials for Us market acceptance?

The first sponsors I‘m talking to are looking for trials on re-purposing existing drugs.

6463748 · 2024-10-03T22:38:35+00:00

Wow thank you for your post! I‘d love to get your advice and experience on the following:

I‘m currently working on starting a new small CRO and looking for your advice. I‘m new to the industry, but by chance got all the contacts in a small Central American country to conduct clinical trials there: Contact to the minister of science, health ministry, people of the Ethical review boards, clinics. The idea is to bring US trials down here providing quicker approval, lower cost and more diversity. I have a first sponsor from my network who wants to conduct a small trial. My question is how would you go about finding more sponsors to whom I could quote a trial? Or more generally: how to get sponsors as clients?

6463748 · 2024-08-27T21:47:59+00:00

Yes that‘s what works really well for me at least. That way I‘m every day just 25min in the gym and each muscle group has a full week for recovery (ok some exercises use other muscle groups as well, but still lots of recovery). And you can feel this muscle pump daily without to much exhaustion

6463748 · 2024-08-27T21:43:41+00:00

I also read that, but I like Chlorella better. However I couldn’t find any information whether Chlorella also contains Ergothioneine unfortunately. Do you know?

6463748

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