Datapharm Australia’s clinical trial monitoring services have always been fundamental to our operations. Our extensive national and international experience over a wide range of therapeutic areas has brought Datapharm well deserved respect and admiration for the standard of monitoring services offered. Our Monitors undergo extensive ongoing training both internally and externally, and have a thorough knowledge of ICH GCP, local regulatory requirements and current industry best practices. We have deep experience in the full spectrum of clinical trials from Phase 1 (first in humans) to Phase IV (post-marketing surveillance) according to ICH GCP principles and local regulatory requirements. With presence in major Australian cities, Datapharm is able to provide monitoring services when and where your company has a need, often without the burden of expensive travel costs.

Clinical Trial Site Feasibility

• Assistance with Investigator selection and site feasibility
  • Selecting the appropriate investigators and sites is critical to the success of any clinical trial. Datapharm has extensive experience in assessing the qualifications, experience and resources of sites and investigators. With our help, Datapharm will ensure only the most suitable investigators and sites are chosen for your trial.

• Assistance with subject recruitment strategies
  • Meeting recruitment targets is one of the most important but often most challenging aspects of clinical trials. Datapharm’s 25 years of experience means that we know the most effective strategies to recruit the participants you need.

Clinical Trial Setup

• Ethics and Regulatory submissions
  • Datapharm’s experienced personnel are available to assist sites will all ethics and regulatory submissions. We can provide full package submissions and meet crucial ethics and regulatory timelines in Australia and New Zealand’s ever-changing regulatory environment.

• Investigator meetings
  • Investigator meetings are an invaluable tool in promoting the good conduct of multi-centre clinical trials. They provide an excellent opportunity to train study investigators, coordinators and other appropriate staff in trial procedures and regulatory requirements. The meetings foster productive exchanges and interactions to review and improve protocols, motivate site staff and cultivate effective working relationships. Datapharm recognizes the importance of Investigator meetings and has the experience to ensure that your meeting will work effectively towards reaching your study goals.

• GCP training for site staff
  • Datapharm places the highest value on ensuring GCP and regulatory compliance. Our experienced monitors are available to ensure investigational site staff understand and observe their clinical trial responsibilities

• Site Initiation Visits
  • Datapharm’s Monitors are highly experienced in conducting Site Initiation Visits and know how to ensure the best site performance, right from the beginning. We provide site personnel with training and guidance, and inform them of their trial responsibilities.

• Clinical Trial Monitoring Management
  • Datapharm develops a monitoring plan tailored to each project.  This clearly outlines all monitoring requirements and expectations, providing the blueprint for all monitoring activities of the trial.

• Development of Tracking Systems
  • Datapharm can create and customize source data verification checklists and subject status tracking systems for your trial.

Clinical Trial Monitoring

• Routine monitoring visits with source data verification
  • Monitoring visits are conducted according to your study’s objectives, purpose, design, complexity, blinding, size and endpoints. Source Data Verification (SDV) is conducted to ensure accuracy of recorded data, and the level of SDV performed can be tailored to suit the needs of your trial. Datapharm’s highly trained and experienced monitors will work with sites to ensure your study is performed to the highest level of GCP and Protocol compliance.

• Pharmacy visits with Investigational Product (IP) accountability review
  • Accurate IP accountability is an essential requirement for any clinical trial. Datapharm is experienced in ensuring the compliance of Pharmacies with all regulatory requirements.

• Review of Investigator Site Files
  • Our monitors regularly review the Investigator Site File (ISF) to ensure that all required documents are correctly filed, thus maintaining a continual “state of inspection-readiness” at all your sites.

• Regular newsletters to sites
  • Newsletters are regularly sent to sites, providing them with recruitment and study updates, site comparisons, protocol clarifications, and FAQS. Being just one part of our overall site communication strategy, Datapharm ensures that sites are kept informed, up to date and motivated to deliver over and above project expectations.

• Monitoring Visit Reports to Sponsor and letters to Investigator after each visit to site

Our reports include all relevant findings and facts, deviations and deficiencies, conclusions, actions taken and/or actions recommended to secure GCP/regulatory compliance. Monitoring Visit Reports are followed up with a letter to the investigator which includes any significant issues discovered during the visit.

• We ensure review and follow up on all reports and findings. Tracking of CRF review and collection
  • Datapharm maintains accurate tracking of monitored and collected CRF documents to ensure its clients are always up to date on their project’s status.

• Creation and maintenance of a Trial Master File (TMF) both electronically and in hard copy
  • Ongoing TMF management is provided throughout your clinical trial. All essential documents are filed and tracked in-house according to your study needs, ensuring GCP and regulatory compliance. Our eTMF solution provides a secure method of providing remote access to study documents wherever and whenever required. We can also assist with archiving of TMF records upon trial completion.

• Site close-out visits

Datapharm understands the importance of the site close-out visit and ensures that sites are closed out in a state of audit readiness. We perform a detailed ISF Review and TMF reconciliation, record archiving details and inform the investigator of their archiving responsibilities.