We tailor our team according to your clinical trial requirements. In addition to Sponsorship, FCE support, Clinical Research Associate (CRA) Support, Site Selection, Project Management and Monitoring, we offer our services for:
- Study Design
- Patient Recruitment Plans
- Data Management
- Safety & Pharmacovigilance
- Medical Writing
- Quality Management & QA
- Regulatory and Reimbursement Strategy Support
We adhere to ICH GCP, ISO 14155, and all applicable regulations and guidelines.
Clinical trial management requires the ultimate attention to detail. Many parallel and conjoint activities are overseen by our project manager who has meticulously drafted a plan with timelines and objectives. The project manager will:
- Provide detailed plans for trial execution.
- Facilitate and co-ordinate all trial phase activities such as site initiation, enrolment, follow up and close out.
- Streamline and expedite critical landmark activities such as TGA reporting, Site Selection, IRB/EC submissions and Governance.
- Schedule meetings as per your requirement.
- Provide minutes to meetings.
- Archive essential documents.
- Establish and maintain open communication channels.
- Manage Clinical Research Associates (CRAs).
We pride ourselves on being the exemplary central contact point between all the key stakeholders, ethics committees, regulatory agencies, vendors, and hospitals. We plan, coordinate, execute, and supervise your clinical trial with a standard of excellence. Our focus is on clear communication, tracking budgets, managing clinical trial tasks and delivering progress reports.
With responsibility for the initiation, management and financing (or arranging the financing) of the trial, the sponsor carries the medico-legal responsibility associated with its conduct. In addition, the Australian trial sponsor is also the entity responsible for:
- Submitting a CTN or CTX to the TGA, if applicable
- Quality and integrity of the clinical trial data
- All delegated functions in accordance with the
TGA: Guideline for Good Clinical Practice
Our service offering extends to trial sponsorship with our trusted partner meeting responsibilities outlined by the relevant regulatory bodies such as Medsafe and the Therapeutic Goods Administration Legislation.
Our site selection process utilizes a proprietary, systematic, objective and comprehensive site selection evaluation process. CROW Clinical has an expertise in the Medtech “start up” space and understands its unique challenges. Our entrenchment and presence as allied health professionals in the clinical environment allows us to be an integral part of the clinical trial network in many faculties of medicine.
A robust patient recruitment strategy is imperative for clinical trial success. We work with a number of different companies on a variety of platforms. We have a network of skilled recruitment specialists that have excellent track records. We are keen to make the appropriate introductions as a sponsor may require.
Field Clinical Engineering
We offer Corporate Ambassadorship. We are your reliable representative or advocate in the clinical environment. Clinical Engineers (Aust and NZ) will become an extension of your company and will be engaged in the full cycle of your medical device trial.
Clinical monitors execute the monitoring plan laid out by the sponsors and investigators of a clinical trial. Our monitors oversee the progress of a clinical trial and ensure that it is conducted, recorded and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirements.
(for clients to attend cases)
Virtual case attendance is now very common since Covid has limited our travel flexibility.
In this new climate of remote case attendance, it is critical to be able to offer the right solution to enable the sponsor to be intrinsically involved in the actual medical procedure. We can facilitate setting up the correct audio visual requirements including live streaming of several camera images, imaging (fluoroscopy), EP recordings, haemodynamics and all medical device screens for seamless virtual case presence.
For a clinical trial to run smoothly it is important to engage many different stakeholders. Our team are experienced trainers in the clinical environment. Whether it is a refresher for the cath lab team or clarifying inclusion criteria with research co-ordinators, our team will expertly represent the sponsors needs in the training arena.
Our Commercialisation service will bring your new products or services to market with targeted finesse and expedience. Our well established network allows for successful distribution, marketing, sales, customer support, and other key functions critical to achieving the commercial success of your new product or service.
Our services include:
- Metrics and Analysis of recruitment marketing initiatives
- Formulation of Market Development Strategies
- Market Penetration
- Business Development Strategies
- Extension of site network
- Commercialisation implementation working with our regulatory partners
- Post market education and training
- Product distributorship
- Product Sales