Bridging the gap between science & business.

Our company has evolved to fill a growing need for our clients focused on strategic advisory from concept to investment and clinical trial readiness. Our services have expanded to provide expert, technical due diligence services to support better decision making in the investment and acquisition process.   

Our Solutions

The Problem

Many emerging biotech and life science companies do not have the same financial or human resources as big pharma to develop their molecule, device and/or digital health product from discovery to commercialization.

Mistakes can be costly and impact the ability for a company to meet their R&D goals.

The AxialBridge Solution

Our company services have gone through an evolution to further meet industry needs and address gaps. In addition to our Regulatory Affairs & Quality Management Services, and our Clinical Trial Management Services, we are providing additional strategic services to support clients pre-phase 1 clinical trials and have expanded our clients to include investors and funders.

At AxialBridge we understand the business of research.

Combining innovation and extensive experience, we take a pragmatic approach to our services to help clients take their idea from concept to commerce. Our work with clients includes a strong collaborative approach; taking advantage of our vast connected network of global expert advisors, preidentified research sites, vendors, and partners.

Strategic Advisory
Services

Technical (Clinical & Regulatory) Due Diligence

Reimbursement & Market Access

Indication Identification and Selection

Scientific, Medical, Regulatory Advisory

Business Development Support

In-House Senior Staffing & Advisory Resources e.g., Interim CMO, CSO etc.

Regulatory Affairs & Quality Management

Early engagement with regulatory bodies and stakeholders

Regulatory Strategy and Regulatory Submissions

Development of Regulatory Documents for Submission

Development and Writing of SOPs to support sponsor and site Quality Management Systems

Quality Vendor Audits (Contract Research Organizations, Diagnostic Centres, Formulation Partners, Research Sites, Data Management Vendors, Drug Depots etc.)

Inspection Readiness Services

In-House Regulatory affairs and Quality Management Personnel

Clinical Trial Management Services

Medical Writing e.g., study design, protocol, IP etc.

Investigational Product Support

Preclinical Advisory

Inspection preparation and readiness

Clinical Trial Monitoring Services

Quality Management Systems and SOP Development

Grant identification and writing

Project Management Services

Clinical Operations Management

Regulatory Submission (Health Canada, FDA, MHRA, EMA, TGA etc.)

Site Feasibility and Selection (supporting CROs and vendors)

Investigational Product Support

PI and essential study team identification and selection

Participant Recruitment and Retention Support

Educational services for sponsors, sites and research teams

  • Case Study 1: Strategic Advisory

    “Biotech Company A” required assistance with their clinical development planning. They have a novel therapy that can be used for a number of indications and they also required funding to be able to conduct clinical trials. AxialBridge provided advisory and helped to identify and select the optimal indication based on reimbursement and market opportunity. In addition, our Regulatory Affairs team initiated early engagement with regulatory bodies and assisted in prioritizing markets and determined where to conduct the clinical trials. Lastly, we helped Biotech Company A with investor readiness advisory including pitch deck development, coaching on how to engage with investors and connecting with AxialBridge’s eco-system partners including investors and other strategic partners.

  • Case Study 2: Strategic Advisory Services

    “Investment Firm A” was seeking to invest in early phase Biotech/Life Science companies (companies that have not yet conducted phase II clinical trials). They were looking to invest in companies that have a novel therapy focusing on an unmet need indication. AxialBridge assisted Investment Firm A by conducting Technical (Clinical and Regulatory) due diligence services in 180 days as per Axialbridge Asset, Risk & Opportunity Assessment™.

  • Case Study 3: Regulatory Affairs and Quality Management Services

    “Biotech Company B” had both an approved device and a drug for Long Covid (developed using AI Drug Discover). They wanted assistance to get ready for clinical trials including preclinical advisory, CMC support and development of their Drug Master File (DMF). In addition, AxialBridge’s Regulatory Affairs team assisted Biotech Company B prepare and met with regulatory bodies to present their preclinical and their clinical trial plan. In addition, AxialBridge’s team conducted the regulatory submission for their approved device and accomplished approval in new markets.

  • Case Study 4: Regulatory Affairs and Quality Management Services

    “Research Site A” was conducting an ongoing psychedelic clinical trial and had a regulatory inspection. They required assistance to address regulatory inspection findings. AxialBridge services included developing site quality management systems including the development of new SOPs and revising existing SOPs. In addition, AxialBridge provided site training and comprehensive response to regulatory bodies detailing all corrective actions and preventative actions (CAPA) that were completed.

  • Case Study 5: Clinical Trial Management Services

    “Global Contract Research Organization A” required subject matter expertise and clinical trial management services to support an ongoing study. AxialBridge assisted with adding new sites and conducting site feasibility and assessment (completed through our network of approved research sites). We provided additional staffing resources to support the study including a Project Manager and a Clinical Research Monitor to support additional monitoring visits.

  • Case Study 6: Clinical Trial Management Services

    “Life Science Company A” required “rescue” study services due to clinical trial delays and lack of participant recruitment resulting in being behind timelines. In addition, Life Science Company A was concerned about the quality of sites that had lack of clinical trial experience. AxialBridge assisted with auditing the problem research sites and assisted to implement recruitment and retention strategies including strategies to enhance diverse populations.