Here the different things to know about the pharmaceutical companies and their staff if you want to be involved in clinical research.
Contact info@trialjoin.com for more information about patient recruitment help, obtaining new studies or help with site management.
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Things to know about pharmaceutical companies from insiders
1. Things to Know About
Pharmaceutical Companies From
Insiders
2. Better understand who to reach out to when you have questions
about your trial or upcoming trials
Provide you clarity on how to interact with Sponsors
Get vital information to discuss why each of these trials are
important and how much effort goes into designing one
After reading you will be able to:
3. Clinical Development/Clinical Operations
Team
• Every sponsor will have a team dedicated to writing the
protocol. Team is comprised of statistician, medical doctor,
clinical operations personnel, and researchers
• External consultants will be hired to construct these
protocols. These external experts possess exceptional skills in
writing a protocol
• Clinical Development/Operations team will have a personnel
dedicated to ensuring that the trial is operating efficiently,
comprised of managers who oversee CRAs/Monitors
4. During this initial feasibility site visit, keep in mind a
few things that you want to prepare
•Have the PI ready to engage in a conversation about the trial
– Why they are passionate about the trial
– What they see as potential benefits
– What they see as potential limitations
– And helping them understand things that may hinder
recruitment
5. Ensure that everything is clean
and organized
Make sure that all Coordinators
working on that specific trial
are present, so they can see
all the resources that you’ve
put behind the trial
All equipment is ready to use
Do NOT introduce these
individuals to patients
themselves
Make sure the site
is ready to show off
6. The Investigator Meeting
• The best place to network and ensure that your site is
recognized
• The perfect time to inform individuals that your specific site
has been recognized as a top recruiting site on other trials
• Also, you invite these Clinical Development/Operations
colleagues to your site for a visit to meet your team, including
the Principal Investigator (PI)
7. Field Personnel to
network with for
more studies
• Individuals that work in
the field and meet with
their customers (i.e. you)
• Field Personnel includes
Sales Reps,
CRAs/Monitors, and
Medical Science Liaisons
(MSLs)
• They have an important
role to play with your site
and each provides a
unique opportunity for
you
8. Pharmaceutical/Medical Sales Reps
•They can triage all your requests internally
•They are extremely visible in the company and make sure
any of your questions get to the right person
•If your question relates to other information, they can call on
the right people to ensure your question is answered at an
appropriate time frame
9. Medical Science Liaisons (MSLs)
• They are part of the Medical Affairs team (responsible for the
medical strategy of the pharmaceutical company)
• They work both internally and externally with customers to
ensure that communication between the internal and
external world is complete
• MSLs are completely aware of the “PIPELINE”
• You can ask the MSL to submit your name to participate in
these clinical trials
10. Medical Science Liaisons (MSLs)
•You can inform them why your site would be a good option,
based on the success you’ve had with them in the past or
similar trials that you’ve worked on
•MSLs love to hear when they have a passionate site in their
territory, since they can come to meet with you frequently
and address any questions that you have
•They take the opportunity to take your PI out to dinner and
create a long lasting relationship with them
11. CRAs/Monitors
• They will visit your site to ensure that you are on track to
complete the trial for each given patient
• They are lifesavers and know the protocol better than
anyone else
•They will ensure that your site is efficient and will also give
tips about what the other sites are doing
•Make sure to keep the dialogue open with these
individuals, because you will be surprised at what you’ll
learn especially if your site is a new one to the Sponsor
12. • They can talk more freely at dinner
• This can spark a relationship that last for a lifetime and
ensure that you continue to get clinical trials in the future
• This will also get your PI more excited about the trial and will
keep recruitment on top of their mind
• This may open up a potential opportunity for your PI to serve
as a consultant to the operations/medical/marketing teams
– but again, this all depends on how excited your PI is when
giving insights to the Clinical Dev/Ops team
Invite them to have dinner with your PI
13. The PIPELINE
• The lifeblood of a company
• Each company has a pipeline that’s rich with drug agents
nearing their maturation phase
• Often times, you can know when a pre-clinical drug is about
to enter into its clinical phase, these are drugs you must be
aware of because phase 1 can come and go quickly meaning
that Phase 2 will be right around the corner
•If you can get on a Phase 2 study with a Sponsor and do well
on it, it’s likely that you will get to work on the Phase 3 study
as well, this is a huge financial benefit to your site
14. Medical Questions when you can’t see an
Monitor
• When you can’t get in touch with an Monitor or members of
the clinical team, then reach out to Medical Information by
calling the company directly from their Contact Us page
• You can ask any question and the Medical Information team
will send you a letter with their response
• These letters are called Standard Response Letters and will be
sent it to you within 24-48 hours and are quick ways for you
to get answers for your PI if they are medically related
questions
15. Who to reach out to when you have questions about your trial or
upcoming trials
How to interact with Sponsors
Why each of these trials are important and how much effort goes
into designing one
Now you should have a better understanding of: