How to start your RELATIONSHIP with Siris:
|
Before starting with any contractor you should, at a minimum, have a CDA (Confidential Disclosure Agreement) in place to protect your project. If you do not have a CDA we can provide a "Boiler Plate" agreement for your review and modification. Once this CDA is in place you can feel comfortable sharing your project needs with Siris.
Two other documents that are also important but not always required are the MSA (Master Services Agreement) and the Quality Agreement. Again if you're interested in these documents Siris can provide "Boiler Plate" documents for your review and modification.
Large or small, your project will be important to us. Let's start by understanding the scope of your project. This can be accomplished by phone. During this conversation we will ask questions about your study, gaining sufficient information to provide a quote. Many of the questions we will ask can be found on the "New Project Checklist". This checklist allows Siris to better understand your needs and will prompt many questions about your project! Knowing how much it will cost you to manage your clinical supply is important information.
Understand your contractor's capabilities and pricing before you send in your quality team. It makes no sense to waste money auditing a facility that you are not going to use because they have not signed off on the CDA, do not have the required capabilities or are too expensive.
Siris welcomes the audit process. It's one of the many areas where we shine! Siris quality systems are robust and more importantly are followed. 80% of all 483's issued by the FDA are for companies not following their own SOP's. The audit process also gives Siris the opportunity to see our operation through "fresh eyes". Comments/suggestions provided during the audit process always benefit our process.
With the following in place, it's time to make your decision and select a vendor to prepare your clinical supplies for distribution:
|
Please tour our site for information on the various services Siris provides.
|
|
