Clinical Research Services

Aginko Research offers comprehensive Clinical Operations Services from Study Start-Up to Submission.

Clinical operations are a critical component in all studies. Aginko Research is well-versed in clinical trial operations including implementing, monitoring and managing the clinical components of a study.

From start-up to close-out, experienced clinical managers and CRAs oversee each study’s clinical processes to ensure proper planning, conduct, patient safety, and data quality while fostering good communication between study sites and sponsor.

Protocol Design

Aginko Research has the experience necessary to deal with the unique challenges of bone and cartilage studies. Our clinical protocol services span across all departments, integrating information from a wide range of expertise. The unique combination of medical, statistical, regulatory, and operational input is unmatched.

What this means to you is that with Aginko Research assistance, the design of your study will efficiently meet its stated objectives and allow you to plan the next set of trials with a high level of confidence. The bottom line is reduced clinical development time with possibly fewer patients and lower costs than expected.

Study Design Activities

Defining the study hypothesis including the definition of key endpoints
Writing the protocol
Designing case report forms
Organizing investigator meetings
Determining the sample size and study duration
Devising a statistical sampling plan to minimize exposure of patients to inferior and/or toxic treatments
Writing interim analysis plans, including the usage of stopping rules for efficiency and futility
Performing analysis planning and related data summary activities
Providing regulatory guidance and insight
Particular expertise in adaptive clinical trials and protocol design

Patient Recruitment

At Aginko Research, we have one objective: to deliver patient recruitment on or ahead of time and within budget. We provide our clients with tools and data to successfully complete patient recruitment on a global scale.

Aginko Research ensures rapid, on-time enrolment through our unique site-based patient recruitment. We take responsibility for enrolment by putting our site and enrolment expertise to work immediately. Our understanding of the dynamics of site-level enrolment and the ability to utilize the right players means that our recruitment management services are more productive.

Project Specific Patient Recruitment Management Strategies

Reduce enrolment timelines
Shorten total study duration
Exceed sponsor expectations
Save sponsor valuable time and money

Our success is due to the constant innovation of our products, unrivalled dedication to our client service and the unique way in which we constantly adapt to an ever-changing marketplace.

Monitoring

All trials are monitored in accordance with GCP.

Aginko Research has a team of CRAs with a considerable clinical research expertise and broad therapeutic experience, allowing us to provide a cost effective solution.

We have co-monitoring and training programs to ensure on-going quality, consistency and up-to-date knowledge in our monitoring.

At Aginko Research, we believe that monitoring is not only about making sure that the project runs smoothly with minimum protocol violations and low query rates but also about delivering a personalised service.

Contracting

Aginko Research provides contracts with fixed service budgets invoiced by milestones according to the study progress. These budgets are based on realistic assumptions agreed upon with our clients beforehand. Unlike competitors in this field, we grant a budget guarantee to our clients.

Changes in orders are only processed if there is an overall change in the study assumptions.

Aginko Research contracts specialised vendors like central laboratories, e-solution providers (eCRF, eDiary, randomisation and trial supply management) or clinical supplies provider according to our clients’ needs.

Biostatistics

Aginko Research covers all aspects regarding statistics. Our team is committed to providing the highest quality services and always works together with the sponsor’s goal in mind, flexibility remains a key priority.

Customized Statistics Services

Statistical advice on study design and protocol preparation
Sample size calculations
Statistical analysis planning (SAP)
Statistical analysis of clinical data incl. validation using SAS®.
Statistical listings and reports
Randomisation according to the major of all possible randomisation plans, including provision of coded lists with treatment information and coded envelopes.