patients first. Using innovative clinical trial management strategies with a focus on patient safety
& advancing new therapies to market.

Therapeutic Area Expertise

Vantage BioTrials has the know-how and therapeutic area expertise to manage your next clinical trial, from the most complicated such as oncology & rare disease, to the more simple generic/consumer health.  You can rest assured that your clinical trial milestones will be planned, designed and completed with success and without compromising quality.

Contact us today to determine how we can add value to your next clinical trial.

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]

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

Our experience includes:

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