Non-clinical Outsourcing and Management
- Non-clinical Outsourcing and Management
- Do you need outsourced non-clinical studies?
- Are you looking for CROs which have exceptionally good records as far as deliverables and quality is concerned?
- Are you looking for a CRO to formulate your raw non-clinical/toxicology plan into a strategic regulatory submission?
- Are you looking for an expert who can evaluate, write and advise on non-clinical, toxicology, safety pharmacology and efficacy reports for regulatory submission?
- Are you looking for a professionally managed company with experts who have years of experience in conducting and monitoring non-clinical studies?
– Then MADE is the right partner for you
MADE can help you in identifying CROs and outsourcing and managing a non-clinical studies portfolio. Dealing with outsourced studies typically involve two processes:
A) Identifying CROs
- MADE helps you to identify and perform technical audits of CROs so that we can ensure that it suits your requirements.
- We organise a tender round.
- We have personally travelled to various CROs to audit them and evaluated their capabilities more precisely – we have signed partnership agreements with only those whom we think could be a best fit for our customers.
B) Managing CROs
- We manage these CRO’s on behalf of our customers in order to ensure the quality and timely delivery of a required information.
- This service includes:
- sending a test item to CRO (including custom formalities)
- the required test item documentation (certificates/MSDS/TIDS)
- study monitoring service (reviewing/accepting the study plan and the report)
- scheduling as planned with the client (deadline check)