What is the study process at Absorption Systems? A. The customer works with our sales team to develop a scope of work (SOW) and pricing for a study. Once the SOW (study outline) is agreed to by the customer, it is used as the basis for a proposal, and the customer must sign and return the signed proposal to initiate a study. The customer then sends test compounds to our facility. Next, the Project Coordinator prepares a study protocol from the SOW (sign-off on the protocol may be necessary for work to begin). The experimental portion of the study is carried out under the direction of the Study Director, such that previously agreed-upon timelines are met. The report is generated and sent through quality control. It is then finalized and sent to the customer electronically or made available via the secure document delivery system of our website.
Who does the sales team include? A. The sales team consists of a Business Development Manager (BDM: regional sales representative) and an Account Manager (AM). The BDM is usually the first contact with the customer. The AM is responsible for much of the subsequent correspondence with the customer.
I am a new customer. Are there any special requirements? A. Yes. A 50% prepayment may be required from new customers prior to study initiation.
Who prepares the Scope of Work (SOW)? A. The Account Manager prepares the SOW. However, it is reviewed, as appropriate, for scientific content by one of our scientific experts.
Who else is assigned to my study? A. A Study Director (SD) is assigned. This person overseas the experimental portion of the study. A Project Coordinator also tracks the progress of all studies to be sure they meet all previously agreed-upon timelines.
What if I want to change the Scope of Work (SOW) or proposals? A. Many of our SOWs and proposals go through multiple revisions. A proposal is only final once the customer agrees to it. Signed proposals can be modified through execution of a change order.
How do I reference my study with Absorption Systems? A. Your study will be given a Reference Study Number at the time of the proposal.
How do I determine if Absorption Systems received my test compound? A. Upon receipt of test compounds, a designated person at Absorption Systems will electronically confirm the receipt of test compounds.
What if I would like additional steps? A. Additional steps, such as in-study updates and post-study quality assurance (QA) audits, are included for GLP studies or upon request by the customer.
Do I have input on the study protocol? A. Yes. Though our Project Coordinator creates the study protocol, the Study Director, Scientific Reviewer, and/or the customer may have input at this stage, as appropriate. The study protocol contains sufficient detail to conduct the study.
I have multiple shipments of test compounds. Do the protocols need to be identical? A. No. Within the same study, multiple shipments of test compounds may or may not be tested according to identical protocols, as appropriate.
Does the report go through quality control? A. Yes. The draft report is prepared by the Study Director and circulated to the quality control reviewer, followed by the scientific reviewer and Project Coordinator.
Can I receive a draft report? A. Yes. The proposal may require that a draft report be sent to the customer for review and comment prior to finalization.
How do I receive the report? A. The report is an electronically signed (in compliance with 21 CFR Part 11) PDF. The report is signed by the scientific reviewer and the Study Director. It is delivered to the customer electronically or made available via the secure document delivery system of our website.
Can I receive my report in other formats? A. Yes. Though our default method of sending reports is an electronically signed PDF, you may also receive Word documents, hard copies, etc., but additional charges may apply.
How do I get a website account? A. This is a courtesy to our customers, and it is invitation only. Please ask your sales representative for an account. You will then receive an email invitation to create your new username and password.
What if I haven’t received my email invitation? A. The email may have been blocked. It is best to add the email address and/or domain name to your safe sender’s list. If you need help, please contact Absorption Systems.
What if I can’t add the email address and/or domain name to my safe sender’s list? A. We can force your account to be created. In doing so, we will choose your username and password, and then we will email them to you. You can then change your password upon your first log-in.
What if I forget my password? A. On the log-in screen, click on the ‘Forgot your password’ link. You will be sent an email to reset your password.
How will I know if my report is ready or a change has been made to my website account? A. You will receive automated emails any time a change is made to your account.
Can I print or save documents from my website account? A. Yes. You can open, print, and save any document you download from your account.