Site Identification, Selection & Feasibility

Identification and selection of the optimum sites, Key Investigators and Opinion Leaders are fundamental to the success of any clinical trial.

Human Health Clinical Research expert’s have local knowledge and teams on the ground to facilitate close contact with investigators and sites. The existing relationships of our teams, with investigators and site staff, is fully leveraged during our feasibility process and throughout the study.

Strong and established relationships with experienced investigators help to facilitate a timely but comprehensive feasibility assessment to ensure the most appropriate and best recruiting sites chosen for our sponsor’s projects.

If you are planning to shorten your study timelines then the Human Health Clinical Research targeted approach to Investigator recruitment, combined with our local experience, may be just what you need.

Patient Recruitment

It is a well-established fact that many clinical trials fail to meet their recruitment timelines. Delays in recruitment increase overall costs as the overall drug development timelines are pushed out with a negative impact on the product launch to market.

At Human Health Clinical Research approach to ensuring accelerated patient recruitment and enhanced patient retention is multi-dimensional. The focus on patient recruitment and retention starts with the selection of the most appropriate sites where our structured feasibility indicates the best chance of recruiting the required patient population within the shortest time period.

In consultation with our sites and clients we utilize well defined processes and tools to accelerate patient recruitment e.g. recruitment projection calculator, site specific recruitment plans, patient outreach approaches, definition of patient flow and logistics etc.

Regulatory Services

Human Health Clinical Research appreciates the significance of high quality submissions to the relevant Ethics Committees to ensure that approvals are available in a timely fashion. We have experts on the ground who have the required up-to-date local knowledge of the submission process. In many cases our Project Managers will undertake the Ethics Committee submissions to make sure that the process is seamless from gaining approval to study start-up. Our team members have a thorough practical knowledge of completing Ethics Committee Submissions. Our teams have successfully completed submissions in some of the most challenging regulatory environments and have a comprehensive understanding of the intricacies of each process which gives them the ability to communicate effectively with the relevant agencies and bodies.

Training

Human Health Clinical Research offers customized training courses to the develop expertise necessary for effective clinical research. The training enables to master practical aspects of clinical trial conduct and management including a clinical trial, guideline, and ethical considerations.

1. 1. ICH-GCP TRAINING
2. 2. CLINICAL RESEARCH TRAINING
3. 3. PARTICULAR THERAPEUTIC AREA TRAINING

Audits and Monitoring

Human Health Clinical Research appreciates team makes sure to maintain accuracy and quality throughout the conduct of clinical study. HHCR has maintained the process of QA throughout the trial as per protocol. Also, Site CRC to prepare the site for Sponsor monitoring or audit.

Data Management

Start up to close out HHCR has highly trained and experienced staff for project/Data management. Our goal is to ensuring quality in project management along with a timeline of associates. Additionally, our team makes sure that they have successfully managed a clinical trial with quality, ethics & guidelines. With their proactive approach toward clients helps them to address in detailed risk assessment and mitigation plan.