Millenium CRA

Your Trusted Partner in Clinical Research

  • Founded in 1999 with a mandate to provide quality and affordable clinical research consulting services to the pharmaceutical, biotechnology, and medical device companies, MILLENIUM CRA INC. offers bilingual (French and English), flexible solutions to meet clinical, regulatory ...

    About Us

    Founded in 1999 with a mandate to provide quality and affordable clinical research consulting services to the pharmaceutical, biotechnology, and medical device companies, MILLENIUM CRA INC. offers bilingual (French and English), flexible solutions to meet clinical, regulatory and safety staffing needs based upon clients’ requirements across a broad range of job functions including Clinical Project Management, Clinical Research Monitoring, Investigative site recruitment, CRF design, translational services, regulatory services, pharmacovigilance, and Site auditing.

    Millenium CRA Inc. Clinical Resourcing Mission

    Encompassing years of experience in the pharmaceutical and CRO industries, we passionately embraced the mission in 1999 to create a unique business model that overcame the traditional challenges often experienced by pharmaceutical companies when outsourcing their Phase I through IV clinical trials.

    Once assigned, Millenium CRA Inc. consultants become an integral part of the client’s team, and using our in-depth industry knowledge, we work hand in hand with the team to ensure that the client’s goals and deliverables are successfully achieved.

    Our unique mission is supported by our repeat business rate of greater than 90%, a testimony of our clients’ faith in a trusted, devoted Clinical Research partner who consistently delivers the outcomes in a professional and timely manner.

    Clinical Research Experience

    • We collaborated with over 50 of the industry’s top pharmaceutical and biotechnological companies, as well as Clinical Research Organizations across multiple therapeutic areas and Clinical Research Phases.
    • Our Clinical Research Consultants average 10 or more years of industry experience.
    • We ensure rigorous compliance with protocol and GCP standards.
    • We ensure flexible solutions to the client’s needs.

  • Our services include but are not limited to:
    • Project Management
    • Clinical Start-Up Services
    • Clinical Research Monitoring
    • Clinical Support
    • Site Management
    • Query Management
    • Safety Management
    • Quality Assurance...

    Services

    Our services include but are not limited to:

    • Project Management
    • Clinical Start-Up Services
    • Clinical Research Monitoring
    • Clinical Support
    • Site Management
    • Query Management
    • Safety Management
    • Quality Assurance Auditing

    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

    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

    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

    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

     

  • Recommendations For Millenium CRA Inc consultants:

    “I had the distinct pleasure of working with Mai Chi on a very complex, very time intense and hugely important Clinical Trial. Mai Chi worked with us to assure that the protocol was followed exactly. She provide...

    I had the distinct pleasure of working with MC (Millenium CRA) on a very complex, very time intense and hugely important Clinical Trial. MC worked with us to assure that the protocol was followed exactly. She provided superb support in achieving the most important goals of the study -- to produce a solid, scientifically valid study. My company was able to achieve a "company first" -- achievement of "Pre-clinical to Clinical Study Completion" in less than 1000 days! MC was critical to this success. I will look forward to working with Mai Chi again soon on further projects in the Clinical Development of a new drug. Dated January, 2014.
    J.F. - Associate Director, Clinical Research at Major Pharma -
    A few years ago, I had the opportunity to work with MC (Millenium CRA) in a large scale cardiology trial with 6000 patients including one third recruited in Canada. Our organization needed a strong team of CRAs to run the Canadian part of the study. MC provided the most experienced and reliable team we had in any of the countries where we run this trial. MC also organized and managed very efficiently all aspects of the monitoring, scheduling and trouble shooting of the Canadian operations. She built a strong relationship with difficult research sites where the workload necessitated the presence on site of several CRAs on a monthly basis. She mapped out a procedure that assured maximum efficacy was obtained within the minimum amount of time. MC promptly provided additional skilled and experienced manpower when the study was growing bigger than originally planned for Canada. It was a stable team with almost no turn-over for the duration of the study which lasted more than three years. We required a lot of flexibility from the team and sometimes had meetings during the week-end. Although this was a challenge, MC always responded enthusiastically and supportively of our requests. This is the finest team of contractors I had the pleasure to work with in my twenty years in this business, and by far. I will keep contact with MC’s organization as I cannot consider a better partner to run complicated trials in Canada.
    Cerexa - Senior Director Development Operation - P. C.
    It is without hesitation that I recommend MC (Millenium CRA) whose qualities include competency, conscientiousness and great honesty. I always enjoy working with this outstanding and professional collaborator. MC is remarkably efficient, communicates with ease while ensuring the interests of all concerned parties are met. I hope your path will cross one day that of MC's.
    D. G., MD - CEO - - Intermed groupe santé
    MC (Millenium CRA) came in on a complex clinical trial on esophageal bleeding. She played a key role in providing competent CRA resources and sound advice in optimizing the patient recruitment process. It became natural to involve MC in other trials in which she and her company continued to perform very well. A key edge of MC is her ability to listen to client needs, interpret the context and come up with alternate solutions that have a strong potential to deliver the results. Marked by a flexible work style and a deep experience, her contribution to projects has always been geared towards one goal: Success!!
    Genome Quebec - VP Administration - D. B. BSc, DIA, MBA
    Debiopharm Group outsourced the monitoring of phase 2 and 3 studies to MC (Millenium CRA) and her team of CRAs to full satisfaction. Audits and FDA inspections of some of those sites led to a positive conclusion regarding both data integrity and respect of regulations. Mai Chi can only be recommended for the high standard of her work, her punctuality at every step of the process as well as her very pleasant personality. In addition MC was of invaluable help for the preparation and during the course of an FDA inspection of Debiovision, Inc., one of the companies of Debiopharm Group, showing a strong sense of organisation and project management.
    D. B. - Director, Quality Assurance, Documentation & Regulatory Affairs at Debiopharm S.A. -
    During my years at Axcan, I was fortunate to work with MC (Millenium CRA) as we outsourced some of our North American monitoring activities to her and her team. Her expertise of the monitoring field and great knowledge of the scientific and operational aspects of study protocols were a tremendous help for us as we needed to conduct challenging studies within tight timelines. MC’s keen ability to detect challenges and opportunities within protocols, study documents and study tools is certainly an asset for her clients as she can proactively identify ways to streamline and improve the monitoring performances within a study. MC’s professionalism and integrity are outstanding as she can balance her dedication to clients’ needs and her working ethics leading to dependable high quality monitoring. I highly recommend MC to perform, manage, or oversee monitoring activities in any type of clinical trials. Her great personality makes it even more enjoyable to work with her.
    Pfizer - Senior Director, US Regional Lead - P. R., PhD
    MC, as CEO of Millenium, provided cost saving services in handling a clinical trial in Canada. She had an outstanding understanding of our needs, as well as a in-depth knowledge of medical science thanks to her previous clinical experience. Her personnal soft skills in communicating with her team and with investigators was of incredible value. I would highly recommend Millenium for its customized and reliable services.
    Dr E. T. - Attending Physician - CHUV Palliative Medicine Dpt.
    Acting as a Clinical Trial Lead at Otsuka, I had the great opportunity to be part of the same team as MC (Millenium CRA) . As a Clinical Oversight Lead, MC was providing Oversight services in a very challenging global pediatric program related to psychiatric disorders - Schizophrenia and Bipolar Disorder. Dealing with research sites throughout the world and differences in regulations understanding within partners, MC always travels with a great touch of intercultural sense of collaboration and provides information and assistance in order that all study team members - internal and external Customers - experience success and sense of great accomplishment. MC, as part of the group, is essential for any team spirit and welfare.
    - Project and Site Manager - S. H.
    I had the pleasure of working with MC (Millenium CRA) and her team at Millenium for few years on a major cardiovascular trial. Millenium performed admirably managing the highest enrolling site in the study as well as all of the sites in Canada. Her team demonstrated professionalism and efficiency resulting in clean data and numerous compliments from the sites. MC managed her team with respect and held them accountable for their performance. I have returned to Millenium for additional work since and will continue to work with Millenium when an opportunity arises.
    C. Y. - Independent Pharmaceutical consultant -
    Mai Chi has earned the reputation of a knowledgeable, highly skilled Clincal Research professional. She understands and practices the role of a Clinical Research Associate with enthusiasm and integrity. Her work is done well and on time. She has been an valuable member of multiple teams in several therapeutic areas.
    PharmaNet Resource Solutions at PharmaNet - Director - T. K.
    MC (Millenium CRA) is a very knowledgeable clinical research professional who has the demonstrated ability to manage a project from the beginning to the end within budget and timelines. She and her team are reliable and always deliver results. On a personal note, MC (Millenium CRA) is a pleasure to work with. She has advanced interpersonal skills and the ability to communicate with all levels within an organization and to build relationships with even the most difficult sites. I have no hesitation in recommending MC (Millenium CRA)
    J. B. - Clinical Research Manager -
    Mai Chi is a highly skilled Clinical Research professional with a great reputation as an Independent Consultant Clinical Research Associate. She has an excellent knowledge of the Good Clinical Practice rules and regulations and has expertise in multiple therapeutic areas and phases. Her interpersonal skills and the ability to communicate with all levels within an organization are superb.
    Shire Pharmaceuticals - Contract IT Supplier Management Program Coordinator - J. H.
    MC (Millenium CRA) is not just a clinical trial monitor. Her wealth of experience, her extensive network and her enthusiasm and dedication to a job well done will make her "the" partner of choice in any clinical trial.
    M. G. - Manager, Center for Innovative Medicine - McGill University
    MC (Millenium CRA) is an efficient site manager with excellent interpersonal skills and superior GCP knowledge and quality assurance abilities. She is extremely professional and respectful, very conscientious and has a constructive approach. I strongly recommend her for any clinical research management duties.
    - Pharmacist - J. L.
    I have worked under MC's direction as well as at her side as a colleague for many years. It is rare to find someone in this line of work who is able to flawlessly combine such professionalism and attention to detail with excellent interpersonal skills. I enjoyed working with her and look forward to being on the same project once again.
    A. T. - Pharmaceuticals Professional -
    I had the distinct pleasure of working with MC (Millenium CRA) on a very complex, very time intense and hugely important Clinical Trial. MC worked with us to assure that the protocol was followed exactly. She provided superb support in achieving the most important goals of the study -- to produce a solid, scientifically valid study. My company was able to achieve a "company first" -- achievement of "Pre-clinical to Clinical Study Completion" in less than 1000 days! MC was critical to this success. I will look forward to working with MC again soon on further projects in the Clinical Development of a new drug.
    - Associate Director, Clinical Research at Major Pharma - J.F.

  • Consultants at Millenium CRA Inc. provide a broad scope of therapeutic expertise in areas including:
    • Allergy
    • Anesthesiology (in CABG)
    • Bone Metabolism,
    • Cardiology
    • Liver Diseases
    • Liver Transplant
    ...

    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

  • • Health Canada Food & Drugs Acts Regulations
    • ICH (International Conference on Harmonization)
    • E6: Good Clinical Practice: Consolidated Guidelines
    • Risk-Based Monitoring
    • Food and Drug Administration Home Page
    • ...

  • Tel: (514) 331-3276
    Cell: (514) 262-4857
    Fax: 1-866-562-2236
    http://www.linkedin.com/pub/mai-chi-nguyen/3/895/110