Promedica International (PMI) provides clinical and regulatory expertise to the medical device, pharmaceutical and biotechnology industries. More than two decades of experience shapes our understanding of the many clinical and regulatory challenges facing healthcare providers and the healthcare industry today.

We are a privately held "S" corporation located in Costa Mesa, California. Our professional staff and consultants have insight and expertise acquired across a broad range of medical specialties/therapeutic areas. Our ISO-certified work processes provide each project uninterrupted consistency, accuracy and attention to detail. These organizational assets - people and processes - are the driving forces behind our goal to provide a level of performance that meets professional standards of quality and reliability for every client, regardless of size or location.

CLINICAL STUDY MANAGEMENT

• Project Management & Administration
• Study Monitoring & Site Management
• Site Recruitment & Qualification
• Site Training
• Patient Recruitment

DATA MANAGEMENT/BIOSTATISTICS

• Data Management
• Biostastics

MEDICAL WRITING

RESEARCH COMPLIANCE & EDUCATION

• Audits/FDA Inspection Support
• GCP Seminars
• Clinical SOP Development

STRATEGIC CONSULTING

• Market Research
• Market Assessments
• Strategic Planning Consultation
• Medical Marketing Study Implementation & Management
• Medical Product Registration

PMI tailors skilled, dedicated project teams to match your project requirements and organizational structure. Our project team members have FDA, industry and healthcare practical experience and understand product development, testing, clinical study and approval processes.

Quality Assurance
We strive for and expect professional quality standards from our project teams. A commitment to quality guides each team member and, ultimately, differentiates us as a contract research organization. Initially developed to better meet, coordinate and mirror the quality systems of our clients, our ISO-certified Quality Management System (QMS) consists of policies and procedures to support continuity, stability, and reduced likelihood of errors or omissions.

Commitment to Training
Your project's success is enhanced by a well-trained, highly skilled team that combines experience with current knowledge. PMI's employees receive formal performance reviews annually where employees and their managers develop objectives to facilitate growth and enrichment, along with programs to achieve these objectives. Our staff is encouraged to identify and participate in programs to sharpen specific skill-sets, join relevant professional societies and participate in their educational programs, and to cross-train.

Professional Management
At PMI, the advancement of your project is not left to chance. At project initiation, you are assigned an appropriate manager who serves as your primary contact and directs the activities of the project team. Your benefit is a single point of contact and accountability with a skilled communicator who understands the importance of - and relationship between - time and money.

We support our managers with formal budget and schedule tracking systems, weekly executive staff meetings to review project performance and issues, work templates developed from previous experiences, and a staffing registry to facilitate identification of resources as needed.

Experienced Study Monitors
Our CRAs are project ambassadors to our study sites. We rely on their judgment and skills to motivate and support study site staff to execute their responsibilities in a quality manner on a timely basis. They are experienced study monitors who have worked on device and pharmaceutical studies, and across a variety of medical specialties/therapeutic areas. We support them with established monitoring procedures and detailed activity checklists customized for each project. And, we utilize proactive prompting and tracking systems to help them keep on top of subject enrollment and retention, as well as IRB/Ethics Committee requirements.

Our compiled experience covers a broad range of therapeutic areas, even beyond the following list. To see a brief description of our most recent experience in any specific area, please visit our web-site: www.promedica-intl.com.

• Anesthesiology/Respiratory Therapy
• Cardiovascular
• Cosmetic
• Dental
• General Hospital/Personal Use
• General/Plastic Surgery
• Hematology/Pathology Devices
• Homeopathic
• Neurological Devices
• Nutrition
• Obstetrics/Gynecology
• Oncology
• Ophthalmology/Optometry
• Orthopedics
• Peripheral/CNS System Drugs

PMI has provided services for more than 100 companies over the past two decades. We are especially proud of our track record with early stage companies introducing "break-thru" technology to the US marketplace.

If you need additional information or wish to contact us, please visit our web-site: www.promedica-intl.com.

Contact Information

Promedica International
Ginger Clasby, Business Development
3100 Bristol Street, Suite 250
Costa Mesa, CA 92626 USA
Phone: 714-799-1617 Ext. 25
Fax: 714-799-1680
E-mail:

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