SERVICES

Has the expertise in clinical operation, MyXMO is a CRO that you can count on. MyXMO has the capacity to offer clinical trial management services. Our organization and operations are scalable to fully cater for our clients’ needs and to meet industry demands.

With our experience in projects with major hospitals in Malaysia, we have the contacts and the network access to investigators according to speciality areas. We believe our recommended solutions will be able to meet industry requirements to provide our clients with the successful outcome of the study. To fulfil client’s specific requests, MyXMO offers tailor made services;

FEASIBILITY STUDY ASSESSMENT

Select right sites to start with by conducting a well-planned feasibility study, MyXMO provides tailored services for sponsors to identify clinical investigators to bring in more clinical trials to Malaysia; develop feasibility analysis to ensure that project plan is designed for the successful outcome and getting a clinical trial done in a timely manner.

PRE-STUDY QUALIFICATION VISIT

Conduct on-site visit to ensure that selected site’s facilities, document storage and access, logistic arrangements and study team members’ qualifications meet the study requirements.

IRB/IEC & Regulatory Submission

Have local knowledge of regulatory requirements and process as well as an understanding of how to apply international standards to the local clinical research environments
Have qualified and experienced staff with local know-how and well verse regulatory process in Malaysia to meet clients' needs
Perform quality control review of each submission in compliance to relevant regulatory authorities and IRB/IEC requirements for pharmaceutical/medical device study

Negotiating study budget and securing approval for Clinical Trial Agreement (CTA)

Understanding the financial interest of local Investigators and Sponsor’s financial viability, MyXMO meets both aspects through effective budget negotiation.

Project Management

Provide project management services and logistics in handling project efficiently & effectively to ensure our clients meet their project goals.
Invest in the right kind of training and provide QC/QA process to ensure that GCP and regulatory guidelines are understood and followed by Investigators and all study team members.
Streamline all processes to ensure that standards are maintained without compromising the effectiveness and efficiencies in organization’s operations.

Clinical Monitoring

Has competent and trained monitors to ensure a trial is conducted professionally and efficiently in accordance with the protocol, adherence with SOPs and in compliance with GCP, regulatory as well as other applicable requirements
Strive to enhance positive relationships with a high level of trust and confidence with all our clients & investigators

Other Services

Provide one-stop services on protocol development & CRF design, medical writing, clinical data management and biostatistics analysis through our local partners.