For more information please contact us at [email protected].

For more information please contact us at [email protected].

With a comprehensive range of services and experience in pain management studies, we can define a clear development plan for your drug, device, or combination product and manage the trial from start to finish.

Through Vantage BioTrials’ data base of investigators, we continuously maintain strong relationships with pain management specialists, neurologists, anesthetists, surgeons, general practice investigators, and site investigator research groups.  As experts in Risk-Based Management, our pro-active approach enables us to continually build and establish vital relationships whereby ensuring that investigators and sites remain engaged throughout the life of a project. Through the use of our proven Quality by Design (QbD) methodologies, we maintain continuous dialogue with sites whereby ensuring efficiency, effective recruitment, and continued retention of study patients.

All studies are monitored by experienced project managers, clinical research associates, and medical monitors. Through their knowledge, experience, and with a forward-thinking and solutions-oriented approach, risk mitigation is always performed for every study in order to identify potential risk factors which may otherwise jeopardize overall study success.

Our team has experience in working with various quality of life and pain questionnaires (e.g., BPI, MPI, MSQ, MSQoL, NIS, NRS, VRS, VAS, etc.) devised to capture responses to therapy. Our site managers also assist study coordinators in training patients to complete self-rated pain scales, reinforcing timely capture and review of responses in patient diary data serving as primary endpoints. They are involved in education, review, and feedback with site personnel to ensure quality and consistency across all study sites.

Our experience includes:

• Cancer pain
• Chronic pain
• Dental pain and soft tissue injury
• Headache
• Migraine
• Neuropathic pain
• Osteoarthritis
• Post-operative/procedural pain
• Rheumatoid arthritis

 

For more information or to request a proposal, please email us at [email protected].

For more information please contact us at [email protected].

Our experience includes:

• Psoriasis
• Atopic dermatitis (Eczema)
• Hidradenitis suppurativa (HS)

 

Success Story

Vantage BioTrials was appointed by its Pharmaceutical Sponsor to manage their Phase IV Post Market Observational Epidemiological clinical trial in a rare dermatological disease. The set enrollment expectation by the Pharmaceutical Sponsor was to recruit 145 patients across 30 Canadian sites within 24 months. This target was set as a realistic expectation given the complexity and challenge of finding patients with the disease, as well as finding health care providers and dermatologists with sufficient understanding of the rare condition.

Vantage BioTrials efficiently completed the study by accelerating the enrollment timeframe by 12 months.  Click here to read more.

Developing the right approach by using protocol design input and working towards a specific regulatory claim and commercial application early in the life cycle is the fastest way to market for medical devices or in vitro diagnostics.

Vantage BioTrials has a deep understanding of the challenges faced in clinical development for medical devices: intense competition, precise regulatory requirements and shortened product exclusivity and life cycle. Medical devices are not like drugs or vaccines. They even differ greatly from each other. That’s why you need a Medical Device & Diagnostics group with the broad experience of our project teams. We have the capability to meet your clinical development needs for both pilot and pivotal studies using efficient study management strategies that can reduce costs and shorten time lines by:

• Developing a well-designed protocol and case report forms (CRFs) to ensure high quality data and efficient monitoring
• Site identification and feasibility analysis
• Support Services to meet ISO 14971-2012 “Application of risk management to medical devices” requirement; management procedures and practices to analyze, evaluate, control, and monitor risk relating to the safety of a medical device throughout the protocol design, development and product lifecycle
• Application to Health Authorities, IRB/EC submission, labeling assistance, and other global requirements. Efficiently managing study start up, and execution in accordance with ICH GCP & ISO 14155-2011
• Risk analysis/mitigation and risk-based monitoring approach

As one of the only Canadian CRO’s that has established a niche for the management of Medical Device trials, Vantage BioTrials has successfully obtained numerous agency approvals, PMAs and FDA 510(k) clearances.

Our experience includes:

• Proof of Concept Studies
• Companion Diagnostics
• Implantables
• Combined Device/Drug Systems
• Orthopedics

Vantage BioTrials will remain focused and dedicated to finding solutions for your study that will realize efficiency and productivity, all the while maintaining quality and keeping your study within cost and timelines. For more information or to request a proposal, please call 514-564-3466 or email us at [email protected].

For more information please contact us at [email protected].

For more information please contact us at [email protected].

With hundreds of Bioequivalence/Phase I clinical trials monitored to date for our Consumer Health, Generic Pharma, Biotechnology and Biopharma Sponsors, and in a multitude number of therapeutic areas, we are the only expert service provider in Canada with so much experience in handling these type of early-phase trials.

Our therapeutically experienced clinical trial specialists will ensure that your trial is managed and monitored properly and without compromising quality.  Through Risk-Based Monitoring, they will ensure:

• Interpreting the metrics, performance indicators, and trends that emerge from a combination of on-site and centralized monitoring to ensure proactive decision making and interventions.
• Continuous flow of study data that is being monitored for trends to enable real-time decision making and action.
• Qualitative reports.

 

Our experience includes:

• BE/BA
• PK/PD
• First in Human
• Multi/Single Ascending Dose
• Proof of Concept

For more information please contact us at [email protected].

For more information please contact us at [email protected].

For more information please contact us at [email protected].

For more information please contact us at [email protected].

For more information please contact us at [email protected].

Our experience includes:

• Hematologic Malignancies/Blood Cancers
  • Acute Myeloid Leukemia (AML)
  • Hodgkin’s Lymphoma
  • Non-Hodgkin’s Lymphoma (NHL)
• Solid Tumors
  • Advanced/Metastatic Solid Tumors
  • Biliary Cancer
  • Brain Cancer
  • Breast Cancer
  • Colorectal Cancer
  • Hepatocellular Carcinoma (HCC)
  • Melanoma
  • Non-Small Cell Lung Cancer (NSCLC)
  • Pancreatic Cancer
  • Prostate Cancer
  • Small Cell Lung Cancer (SCLC)

Our experience includes:

• Age-related macular degeneration (Wet and Dry)
• Conjunctivitis
• Diabetic macular edema/diabetic retinopathy
• Dry eye
• Glaucoma/ocular hypertension
• Cataract
• Uveitis

Performing clinical trials in a pediatric populations have many complexities to consider. Similarly to any other complicated trial (e.g. rare disease), Vantage BioTrials’ decision making process is guided by certain principles which are based on a profound understanding of the subtleties of a pediatric population, including ethical considerations and the many operational complexities involved, such as during the informed consent process, dosing administration and blood draws. As part of our “know-how” in conducting pediatric clinical trials, we focus on and address, trial complexities, patient needs, and of course parent concerns — all with the goal to drive better results for your patients and trial.

Our team focuses on patient- and family- centered approach to protocol development and study conduct to improve participation, accommodate patients’ needs, and successfully support your clinical trials from start to finish. We endeavor to identify the best sites, maximize patient recruitment and retention, and manage all technical and logistical challenges to ensure your treatment reaches the children who need it.

For more information please contact us at [email protected].

Rare disease/orphan drug trials have unique challenges with respect to clinical trial management, investigator/site selection, and patient recruitment/retention. Ensuring the implementation of Risk Mitigation strategies throughout the lifecycle of the trial is key in assisting with the identification of several critical factors:

• Understanding and maintaining strong collaborations with patient advocacy groups and key opinion leaders to create deeper study awareness and support.
• Ensuring that trial protocols are realistic given any limitations of the target patient population.
• Engaging physicians with pediatric experience to understand the study design and complexity involved.
• Remaining patient focused to boost trial enrollment and retention by providing quality subject support materials to demonstrate the benefits of participation.
• Creating a set of study branded tools to help sites identify potential patients as well as educate them about the study and its requirements.
• Regulatory understanding and consultation surrounding the unique environment for rare disease studies.
• Site relationships with access to patient registries to drive patient enrollment.

Our experience includes:

• Multiple Sclerosis
• Rare Cancers (such as Adrenocortical Carcinoma (ACC), Glioblastoma, Esophageal cancer, Chronic Myeloid Leukemia)
• Rare Eye Diseases (such as Wet AMD, Diabetic Retinopathy, Retinitis Pigmentosa)
• Porphyria
• Cushing’s Syndrome
• Cystic Fibrosis
• Familial Hypercholesterolemia
• Fibrodysplasia
• Gastroparesis
• Glomerulonephritis
• Hidradenitis Supurattiva (HS)
• Renal Vasculitis
• Tinnitus

Vantage BioTrials will remain focused and dedicated to finding solutions for your study that will realize efficiency and productivity, all the while maintaining quality and keeping your study within cost and timeline. For more information or to request the proposal, please email us at [email protected].

For more information please contact us at [email protected].

For more information please contact us at [email protected].

For more information please contact us at [email protected].