Since its foundation, Max Neeman International has successfully managed over 100 projects for more than 25 clients. Every project is assigned to a Project Manager who is experienced in all aspects of handling a successful clinical project. The company utilizes a team-oriented approach, leveraging the years of experience that each member has, along every step of the process, thereby providing the client with a high quality service, at the same time ensuring that all timelines are strictly adhered to.
Max Neeman works in partnership with its clients to ensure that the project is effectively and efficiently managed. The company has years of experience in managing the various aspects of a clinical trial - this enables it to offer its clients a wealth of knowledge and information to assist them through all the clinical and regulatory processes.
The ApproachThe Max Neeman project management team has members from each of the functional departments bringing in a wealth of knowledge and expertise to ensure that the project will meet the client's requirements.
Through meticulous planning and co-ordination, the team strives to deliver projects with a clear focus on providing quality backed by on-time and on-cost deliverables. The project managers provide leadership and direction to build a top-notch project team. They serve as a primary resource and a single point of communication for the different projects.
Under the Project Management umbrella, Max Neeman International offers the following services: Site identification based on:
- Patient load
- Investigator's qualification and interest
- Hospital infrastructure and resources
- ICH/GCP trained staff availability
- Papers published by the Investigator
- Investigator's and site's previous experience on clinical trial
Complete site feasibility with infrastructure and as per protocol-specific requirements and specifications
Site qualification visits to check:
- Hospital infrastructure
- Resources
- ICH-GCP trained staff availability
- Lab facilities
Initiating Budget negotiation and Clinical Trial Agreement (CTA)
Initiating and submitting for Ethic Committee approval as per guidelines, backed by follow-up and query resolution, if required
Preparation of Regulatory dossier, submission, follow-up and obtaining requisite approvals
Clinical Trial Material management and coordination
Organizing Study kick-off meeting and Investigators' meeting
Patient data scan and short-listing of patients for chronic diseases
Site initiation visit to confirm:
- Attendance of all team members
- That the team has received and read the study-related material
- The PI is prepared to discuss delegation of tasks
- The team members are prepared on:
- Inclusion/exclusion criteria
- That proper storage of the CTM has been ensured
- That all equipment required to conduct study-related procedures has been assembled/calibrated
Assisting investigators in the Informed Consent Process
Coordination and management of laboratory samples, courier and follow-ups of lab reports
IVRS (Interactive Voice Response Services) for patient's randomization in randomized studies
Investigational product - management and dispensing, temperature monitoring and accountability
Preparation, attendance and follow-up of monitoring
Completing CRF entry with minimal error (All Max Neeman CRCs are trained and certified to log both hardcopy CRF and eCRF)
Preparation, attendance and follow-up of Audit
Data clarification questionnaire
Trial closeout: Preparation, attendance and follow-up; forwarding the necessary information of closeout to clients.
