To support the medical product development in clinical trials and the pharmaceutical company’s medical product development, MyXMO has the requisite skills and abilities;
- Well verse with local regulatory requirements
- Experienced and dedicated team in meeting clients' needs
- Established good working relationship with its clients and work together for the progress in clinical trials development
- Utilize in house comprehensive database to identify the potential investigators - developed a database in house which provides 'ready' access to a large pool of fully GCP trained investigators to help our clients to access large pool of patient population for clinical research in Malaysia
- Strengthen clinical research skills & best practices for sponsor benefits through
- Relationships with experienced research sites
- Access to established centres
- Adherence to project timelines projected according to sponsor request
- Ensuring highest clinical data quality
- Compliance with ICH GCP guidelines, Sponsor SOPs and Regulatory requirements
On Clinical Research Project Coordination and Management, MyXMO will be responsible in
- Collaborating with sponsor and partners in developing medical products through various phases of clinical trials
- Facilitating Medical Product Development by enabling access to available medical products that are not yet approved for use, when necessary, through an appropriate clinical study
- Managing clinical trial to ensure that the standards for safety and efficacy of investigational product are met
- Ensuring the standards on quality and performance of clinical trials to assess investigational products are met
- Providing services to medical product sponsors to obtain regulatory approval to conduct studies in Malaysia
- Ensuring that sponsor has adequate support for medical product development and enabling preparedness and response activities on clinical trial approval
Opportunity
- More trials are shifting to Asian countries
- Government initiatives in promoting Malaysia as the destination for clinical studies
- Malaysia has an increase in the market for local CRO services from international and local companies due to logistics reasons
- Malaysia has population of 30 million with GDP larger than some countries in South East Asia region
- Untapped potential of investigators’ ability in conducting Global studies in Malaysia
- Availability of hospitals with good infrastructure in conducting clinical trials in various therapeutic areas
- Ability to offer competitive prices as a local CRO for our services rendered in terms of ROI (Return of Investment) for clinical trials
Our Strength
Organization
- Ability to support Ministry of Health initiatives in promoting Malaysia as the destination for clinical research in the region
- Ability to provide localized experiences for the global clinical research development
- Ability to provide tailor made services to meet clients’ needs
- Has efficient procedures, system and well developed SOPs and job description to ensure quality work. Our “Do it right the first time” policy will help ensure processes are in place for the services rendered by company
- Has conducive working environment and awareness of company mission, objectives and policy
- Has cost effective system using electronic fund management with the deployment of computerized cash flow system that will make tracking and managing invoices and payments more efficiently
In view of the rapid changes in the business environment, MyXMO will
- Provide one stop services which complement clients’ core businesses
- Build on company competitive strength in providing services in niche markets
- Provide high-quality service at a competitive pricing
- Adhere objectives and guidelines of government policies
- Determine the influence on client’s preference for the type of product/services that are effective and efficient product delivery based on
- Quality of services rendered
- Timeline compliance with clients completion dates
- Timeline compliance for regulatory approvals
- Competitive pricing
Team Members
The CEO/Project Manager of company has vast experiences in project management in clinical research studies for pharmaceutical & medical device companies
The Team Members of company are
- GCP trained
- Knowledgeable, experienced and skilful in conducting clinical trial efficiently & effectively
- Loyal and supportive in sharing the same goal to spear head company to greater heights
- Committed in their involvement in providing services through delegation and trust
- Focus on end results, willing to go beyond extra miles to meet clients’ needs and achieve it
