Request for Proposal:
In support of this pre-clinical safety study in cynomolgus monkeys we require the services outlined below. Please submit this RFP with the names of the project manager and team members who would be assigned to this project.
Response should include the following sections:
1. Management Approach:
1. How will you keep the projects on track?
We will develop a schedule involving a timeline of all the major steps involved in the project. People working on the project will have clearly communicated objectives and tasks to accomplish work in an orderly and timely fashion.
2. How will you deal with adversity?
We can develop a number of secondary plans that could be implemented if we are faced with many obstacles. We could also institute training sessions that will ask employees to think critically about solving problems. This type of training session could prompt open communication and allow for learning opportunities of how colleagues approach adversity. Should something adverse occur, there will be immediate communication to those affected by it (such as superiors, other technicians, or downstream units).
3. How will you keep us informed of progress/adversities?
We can develop checkpoints that involve major steps in the project that could involve meetings. We will also be in daily correspondence to make sure nothing is overlooked, and things remain on target for completion. This also ensures that we share the same goal and vision for how the project should progress.
4. What scientists/statisticians/administrators will be working on this study?
We would have scientist’s adept at pre-clinical studies. They would be knowledgeable when it comes to detecting signs of toxicology and effectiveness of the drug being tested. We will also have a veterinarian and related staff to help monitor the study in the monkeys. We would also have statisticians who will analyze the data and recognize significant relationships presented in the data. We will also have employees who are in charge of the business side of the operation including administrative assistants, project managers, and research and development consultants.
2. Specific Testing Methods:
1. What kind of tests is your lab capable of?
Our lab is capable of toxicology studies, absorption studies, and pharmacology studies.
2. Is there any expertise we can utilize as a readout of our studies?
Our research scientists are highly trained and will have many years of experience to bring to the table.
3. Past Experience with Cynomolgus monkeys:
1. How many cynomolgus monkeys can your facility house/ethically care for?
The facility can house 20 monkeys, and these will be cared for by a veterinarian and assistants trained specifically to deal with monkeys. We will strictly abide by the Animal Welfare Act (AWA) set of standards for care of lab animals.
2. Has your CRO worked with cynos and cyno samples before?
Yes, our CRO has some experience working with cynos. We also have experience working with mice, rats, and dogs. These animals have been previously used in preclinical projects associated with other companies.
3. How many lab techs are trained to handle and extract samples from cynos?
We have 5 lab techs that are trained to extract samples and handle the cynos. They have gone through in person training specifically for this species of monkey and they are confident in handling samples for downstream processing.
4. Quality Assurance Systems:
1. What quality of work can be guaranteed?
We pride ourselves on providing timely and accurate results and working intensively on projects to see them to completion. This is aided by accurate and effective record keeping and documentation. Additionally, internal audits could be performed to evaluate the effectiveness of our own controls and processes.
5. Pricing- Submit a budget with details of the price per task. (Richard)
The anticipated schedule for this study is as follows:
a. IRB approvals- 3-6 weeks (prior to beginning study)
b. Site Initiation Visits- 1 day
c. Initial Toxicology Results- 4-6 weeks (concurrent)
d. ADME Results- 6-12 weeks (concurrent)
e. Preliminary Statistics – 4-12 weeks (concurrent-periodic updates?)
f. Final Case Report- 2-4 weeks
g. Estimated total duration – 22-24 weeks (~6 months)