Things to Know About Pharmaceutical Companies From

Insiders

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:

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

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

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

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)

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

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

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

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

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

• 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

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

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

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: