Your end goals are our guide as we create and execute a plan to meet your objectives. Efficiency is always on our mind as we help you manoeuvre through every phase of the complex and evolving drug research and development process.

In clinical operations, service is coordinating the work of dedicated professionals who monitor product safety, clinical, medical, and regulatory compliance from study start-up through completion In medical writing, regulatory affairs, quality assurance, and data standards, it’s about flawless preparation of regulatory applications and submissions and ensuring compliance with good clinical practices In clinical data management and biostatistics, we understand that the data must be collected and analyzed in ways that optimize opportunities to make broad labelling claims and true research breakthrough

EERA Clinical Partners provide Clinical Development and Operations support in various therapy areas to include:
Therapeutic Portfolio/product review and positioning
Planning of clinical trial programmes from early development to registration

Design and preparation of clinical trial protocols

Medical monitoring of clinical trials with 24/7 coverage

Medical writing, including clinical study reports, investigator brochures, etc.
Interactions with key opinion leaders, preparation of advisory boards, etc.
Expertise in many therapeutic areas for NCEs and biological
Protocol development and consulting
Medical review of informed consent and CRF design
Development of individual study medical monitoring plans
Investigator brochure development
Site selection and enrolment enhancement solutions
Key opinion leader network development
Scientific and medical support for project management teams and sites Laboratory data review
Medical data coding and review
24-hour on call medical monitoring for protocol queries and site support, medical/safety issues
Regulatory agency support and interface
End of study tables and listings review and scientific manuscript drafting/review

Medical Monitoring services divided by the stage of the study: Therapy area training

Pre study start up activities

During the study conduct and

Post-trial activities

Pre study start up activities:
Therapy area training

Clinical development planning

Study document review and input (IB, protocol, CRF, ICF, study manual, SAP)

Review of risk-based monitoring plan

Advice on optimisation of data value

Input in site feasibility if required

Investigators meeting to provide protocol specific training to site staff

Set up Data Safety Monitoring Boards (DSMBs) and Data Monitoring Committees (DMCs).

During the study conduct:

Provision of 24 hour medical monitor (Qualified Physician) cover contact for relevant study and suitable back is available.
Support for clinical trial sites and trial monitors
Investigator and staff training
Answering questions on individual patients eligibility, deviations, Interpretation of protocol procedures, laboratory values and results of other investigations
Medical advice on safety issues, including reportability of events
Input into SAE management
Review of specific laboratory parameters of interest and that may affect patient safety.
Medical support for Project Teams including advising on strategies to improve recruitment.
Advice on emergency unblinding.
Medical review of DSURs including any changes to the benefit-risk, medical review of interim data.
On-going Medical review and advice on Data cleaning activities.

Post-trial activities:
Medical review of post-trial documentation for final clinical study reports

Label review for MAA

Participation in post-trial data review meetings including scientific advisory boards

Review the table and listings for planned statistical output

Writing and review narratives for the clinical safety report

EERA Clinical’s team of physicians is accessible to investigators, study team members, and sponsors 24 hours a day via cellular phone or email. We assign one physician to each study as the “primary team member,” and a second physician, who is also fully familiar with all aspects of your project and detailed protocol, to assist you when the primary physician is not available. Our physicians fully monitor and participate in all phases of each project, including interactions with investigative sites regarding protocol interpretation, inclusion and exclusion criteria for patients, assessment and management of medical and laboratory data, and noted safety issues that arise during the course of a clinical trial. This service is available to investigators and the study team 24 hours a day.