Contact

☎ CONTACT

mai.chi.nguyen@milleniumcra.com
+1 (514) 331-3276

Clinical study start-up services

Millenium CRA Inc. provides a range of flexible services in support of our clients’ clinical study start-up needs.

Services include:

• Site Feasibility / Qualification

• Identifying and Recruiting Investigators

• Patient Recruitment and Retention

• Negotiating Investigator Contracts

• Investigator Meeting Preparation/Management

• Clinical Monitoring Plan/Tool Development

• Clinical Project-Specific Training

• Site Regulatory Document Collection / Processing

Quality assurance services

Our rigorous compliance with protocol and quality standards ensures the successful completion of our clients’ clinical studies.

We provide Quality Assurance services for:

• CRO Oversight on behalf of Millenium CRA Inc. clients

• Clinical investigator site audits

• Vendor audits

• Trial Master File audit

Therapeutic areas

Consultants at Millenium CRA Inc. provide a broad scope of therapeutic expertise in areas including:

• Allergy

• Anesthesiology (in CABG)

• Bone Metabolism

• Cardiology (Atrial Fibrillation, CHF, post-CABG prevention of re-stenosis)

• Devices: hip and knee replacements

• Endocrinology (diabetes)

• Gastro-enterology (functional dyspepsia, diabetic gastropathy, ulcerative proctitis)

• Infectious Diseases (Community-Acquired Pneumonia, C. difficile Associated Diarrhea, Hepatitis C, HIV, Influenza, Intra-abdominal infections, Nosocomial Pneumonia, Pelvic Infections, Sepsis, Sinusitis, and SSTI)

• Liver Diseases (Hepatitis C, Variceal Bleeding)

• Liver Transplant, Intensive Care (ARDS)

• Lung Diseases (Allergy and Asthma; Cystic Fibrosis)

• Neurosciences (phase II/III Acute Ischemic Stroke - 3 studies, ALS, Alzheimer’s disease & vascular/mixed dementia – total of 12 studies, MCI - 3 studies; Multiple Sclerosis)

• Nephrology (anemia in hemodialysis and peritoneal dialysis, hypercalcemia in hemodialysis population)

• Oncology (including breast, lung, renal cancers, Acute Promyelocytic Leukemia and Mesothelioma)

• Psychiatry (including unipolar/bipolar depression, treatment-resistant depression, and schizophrenia) - total of over 40 protocols

• Pain Management (Post-herpetic neuralgia, HIV-related neuropathy)

• Thrombolytic Therapy (in hip and knee replacement)

• Bioequivalence monitoring study

Clinical monitoring services

• Site qualification, initiation, monitoring and closeout

• Remote monitoring and query resolution

• Ongoing site management and communication including regulatory document responsibilities, pharmacy training and drug accountability

• Recruitment planning and tracking, troubleshooting, staff training and motivation

• Ensuring ICH-GCP, confidentiality and safety requirements at the investigative sites are met

Project management services

Millenium CRA Inc. has consistently provided the proven leadership, experience and flexibility needed to oversee clinical studies, some of which resulted in new blockbuster drugs entering the marketplace.

Our Project Management services encompass:

• Investigator site selection and feasibility assessments

• Contract and budget preparation, negotiation and administration

• Regulatory documents coordination

• Investigator meeting organization and site staff training

• CRA resourcing, training, mentoring and support

• Coordinating teleconferences with clients, clinical research teams, vendors and sites

• Managing clients’ expectations for successful achievement of milestones and on-time, on-budget performance