At Mediford Corporation, study initiation and its operation are handled by specialized teams. An appointed project manager supervises both stages.
Once a contract is signed for clinical studies, a project manager (PM) is appointed to each study. Project manager manages all stages of the study from initiation to completion.
Under PM's instruction, during the initiation stage, "Study Design Personnel" prepares Study Specifications Documents (SSD) and determines the composition of kits such as tubes / bottles to be used for blood drawing and urine collection, as well as detailed system design for database setting.
Once the sample collection kits are delivered to each investigator site which conducts the study, the operation stage begins. At this point each study is performed by the operation team. "Study operation personnel" promptly responds to various daily requests from sponsors and investigator sites, including collected samples pickup and test results reporting. Project manager and "Study operation personnel" ensure smooth progress of the studies toward completion.
e-MADAM (e-Mediford Corporation Advanced Data Management System), a system developed based on CSV (Computerized System Validation) procedure, manages the registered information for each study protocol. Using e-MADAM, mediford provides test reports using the terminology described in each study protocol, or in a format which a client desires.
All information such as samples' matrix, patients' demographics, and test results are managed by e-MADAM. Consequently, it enables web browsing of test data ("e-MADAM plus") and provision of electronic data sets for clients' data management departments to realize quick access for clients to check important data.
At Mediford Corporation, two types of plans are available for preparation for clinical studies, "Standard Plan" and "Limited Plan".
For "Standard Plan", duration from the preparation of SSD (Study Specifications Document) to the first delivery of sample collection tubes/materials (the combination is called "material set") is approximately 7 weeks. In this plan, SSD is prepared taking into consideration the requests from the clients.
For shorter initiation period requirements, "Limited Plan" is an option. In Limited Plan, by reducing study-specific customization and applying mediford's standard specifications, the lead time from SSD preparation to the delivery of material sets can be shortened to approximately 5 weeks (*). For example, contents of test requisition form, composition of sample collection tubes/materials, names of test items, order in which test items appeared on test report, etc. will be prepared to mediford’s standard specifications.
Actual preparation period varies depending on each study design, by the type of blood collection tubes used, and/or the quantity requested.
For further information, please consult your mediford sales representative.
Each study/clinical trial is managed by a single project manager (PM) assigned to the study for all the central laboratory services throughout "initiation", "operation", and "completion" stages. Prior to study initiation and operation stages, PMs provide extensive training for mediford's staff in charge of each study.
A kick-off meeting will be held between the sponsor and mediford. Here, mediford PM team will obtain necessary information/requests from the sponsor to prepare "Study Specifications Document (SSD)", which is crucial for the study design, as well as confirming the necessity of outsourcing and the overall time schedule of the study.
At the kick-off meeting, key events for the study progress will also be confirmed with the sponsor, such as the first delivery date of sample collection material set and the scheduled first sample collection date of the first subject. (The date is referred to as "first patient's first visit".)
Specific arrangements will be determined, such as selecting outsourcing companies, ordering procedures, communication flow between parties involved, and requirements/methods for sample transportation.
At the operation stage, mediford PM team reports test results, supports monitoring of the study progress using mediford's core system, e-MADAM (e-Mediford Corporation Advanced Data Management System), and solves various inquiries ("queries") related to sample collection and its submission. We also respond to any minor and major changes of study design.
In case of occurrence of an expected incident, mediford will take immediate action to investigate the root cause in conjunction with our quality assurance department and take effective countermeasures (CAPA).
When the study period ends and the sponsor provides mediford with notification that the study ends, we will carry out the study termination procedures. We also consult with the sponsor the following matters and make a contract to ensure long-term services if required: management of study-related documents kept during the study period (which may be required for application to PMDA; Pharmaceuticals and Medical Devices Agency); management of “residue samples” after performing the planned testing; and management of sample stored for future purposes.