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|Why Use Pharmaceutical Outsource Solutions?|
Why use Pharmaceutical Outsource Solutions?
Your time is a limited commodity. The time you spend finding and setting up outsourced testing will not be spent doing other important activities for which you are responsible. Once the activity is initiated, the time you spend managing it is also lost doing other important work. We can find the right service provider, set it up and even manage it on an on-going basis for you. We can work to ensure that the contract service provider understands and meets your time line requirements.
Money is well spent when the service it buys achieves the desired outcome. With any other result, your money is wasted. Worse yet: poorly conceived and executed testing activities must be repeated to support your product filing. A small investment in expertise can be your best insurance against repeating testing later in the program.
No one does everything well. You will have no way of telling if a particular contact research organizartion (CRO) does your type of activity well or not. One way to surmount this problem is to partner with someone who has a history, direct or indirect, with the service provider and can assess whether they are a good "fit" for your work. Besides this ability to "play to a company's strength" additional quality and control over the activity can be maintained by engaging a partner well versed in the management of these activities to supervise it on your behalf.
How we help you
Many small companies do not have the resources or breadth of experience to setup and manage a successful, well-run GLP- or GMP-compliant testing activity at a CRO. We talk to the sponsor and determine all of the aspects of the testing activity. We then prepare anything from (minimally) a choice of facilities from which to select that will meet the needs of the sponsor to (more completely) prepare and send out RFP, select the site, and manage the establishment of and on-going logistics of the outsourced activity.
Flexibility for your convenience
Clients can initiate a project with little or no forewarning; this is one of the benefits of working with a dedicated consulting service. We work from our own offices but go on-site to meet with clients, as required. We then develop the outsourced activity plan, and go on-site to the CRO, as required, to manage any set up of the activity. The routine management of an outsourced activity is managed via e-mail and teleconference on a daily/weekly basis.
Standard Operating Procedures
Compliance and Techical Auditing
Training and System Implementation
Trouble Shooting and Data Validation