Clinical Research

Clinical Research

At ProRelix Research we focus on Quality, Ethics and Well-being of the clinical trial subject. ProRelix Research offers Phase II to IV services in compliance with Principles of ICH & GCP and provide leadership and management to clinical researchers to ensure the timely initiation, execution, and delivery of clinical trial projects. We provide quality services that result in authentic, verifiable and accurate data.

We believe in offering unique expertise in various therapeutic areas and provide services either as an independent team or working along with the client’s own management.
We follow following process to secure all the necessary steps of a clinical trial project run smoothly:

Setup

  • Medical Writing

  • Translation of Documents

  • Insurance Identifying, selecting and recruiting investigators

  • Negotiating budgets and contracts

  • Submissions to Regulatory Authorities and Ethics Committees

  • Importing products

Conduct

  • Organizing and running meetings with investigators

  • Reviewing and approving reports on monitoring visits

  • Data Management (paper and EDC)

  • Monitoring Visits

Close Out

  • Closing Sites.

  • Disposing of products

  • Report Writing

We believe in offering unique expertise in various therapeutic areas and provide services either as an independent team or working along with the client’s own management. Find below of our services in Clinical Research.

FEASIBLITY: (ASSURED TIMELY ENROLLMENT)

PRORELIX RESEARCH believes that close working relationship with our investigators allows PRORELIX research to identify the geographic areas well known for the prevalence of the targeted indication. All regulatory requirements are then reviewed and timelines developed for each country to ensure that regulatory approvals will permit adherence to the project timelines. PRORELIX RESEARCH then works directly with the most suitable sites in each geography. Sites are only considered if they have proven they can deliver a combination of acceptable enrollment, high subject retention, and data quality. Further, each site is requested to identify potential patients in advance of study start-up, thus increasing the likelihood of meeting enrollment targets.

A rigorous assessment of country and site level feasibility is critical to trial success and must be implemented early in trial planning. Without detailed and accurate feasibility data on which to base country and site selection, a reliable prediction of enrollment rate and therefore successful planning of trial milestones is impossible, which in turn compromises the success of the trial.

SITE SELECTION:

Site selection is a critical element of a successful clinical trial.

PRORELIX RESEARCH site selection criteria are based on four guiding principles

1. Predictability: the site should have a history of accurately predicting the enrollment of the required patients

2. Enrollment: the site should have a history of enrolling the specified number of patients

3. Retention: the staff and the procedures at the site should be professional and diligent enough to ensure proper patient retention

4. Data Quality: the site should have the experience, staff, and methods in place to ensure quality data

PRORELIX RESEARCH’s extensive experience with clinical trial units and hospitals, has enabled us to develop close links to a large number of high quality, motivated investigational sites with high recruitment potential. We also have a clear understanding of site capabilities to ensure that sites possess the equipment and skills to perform non-standard clinical procedures. We select sites based on their history of meeting enrollment targets and consistent delivery of high quality data.

During the feasibility stage, we work with the site team to identify prospective patients before study initiation, thereby giving clients the security of firm enrollment targets. From that first contact to the final database lock, our staff tightly manages the efforts and outcomes of every patient interaction, thus ensuring full enrollment and on-time execution.

When PRORELIX RESAERCH is responsible for site selection, we guarantee full enrollment according to originally agreed timelines by using our Feasibility approach.

REGULATORY AFFAIRS:

The key to fast regulatory approvals for clinical trials is based on understanding the ever-changing global and local regulatory landscape, combined with on-going professional relationships with regulatory personals in each country.

PRORELIX RESEARCH has both. Our regulatory team is constantly monitoring the regulatory environment of the global pharmaceutical and biotechnology industries, keeping track of changes in all local legislation, guidelines and regulations.

PRORELIX RESEARCH Regulatory team consists of local staff with a deep understanding of that country’s regulatory requirements. Our staff will work alone or in-concert with the sponsor’s Regulatory team. Together we will develop the strategic regulatory plan for the study, identify the best countries to be involved, and assist the sponsor in working with regulatory authorities and ethics committees, coordinating translations, and negotiating contracts with sites.

REGULATORY AFFAIRS:

The key to fast regulatory approvals for clinical trials is based on understanding the ever-changing global and local regulatory landscape, combined with on-going professional relationships with regulatory personals in each country.

PRORELIX RESEARCH has both. Our regulatory team is constantly monitoring the regulatory environment of the global pharmaceutical and biotechnology industries, keeping track of changes in all local legislation, guidelines and regulations.

PRORELIX RESEARCH Regulatory team consists of local staff with a deep understanding of that country’s regulatory requirements. Our staff will work alone or in-concert with the sponsor’s Regulatory team. Together we will develop the strategic regulatory plan for the study, identify the best countries to be involved, and assist the sponsor in working with regulatory authorities and ethics committees, coordinating translations, and negotiating contracts with sites.

PROJECT MANAGEMENT:

Ingenious | Diligence | Attention to detail | Adaptive Approaches

Project Management is all about keeping your clinical trial on-track and on-time.

PRORELIX RESEARCH delivers.

Maybe you are aware of PRORELIX research’s End to End Guarentee, assuring sponsors of no CRO-initiated change in scope or change in price. We consistently deliver on this promise through the intelligent execution of our Project Management team.

How can we achieve this?

Project Managers are assigned to a project based on their experience and familiarity with the specific therapeutic area and indication. This prevents costly data errors and provides effective communication between the client, sites, CRAs, and the project team.

PRORELIX RESEARCH makes training a priority and all our staff undertakes a specific and personalised training program. This means you can rely on the quality of our project management team assigned to your study.

You will find that the PRORELIX RESEARCH project teams are characterized by their proactive approach to identifying potential issues and their provision of well-considered solutions. Our teams do not merely create a list of questions to ask our clients! Our organisational structure also allows direct communication with all levels of management and rapid response times meaning our senior management remains in close contact with your project.

The PRORELIX RESEARCH project team consider themselves part of your team: together we agree the best solution.

Adaptive Project Management

Using this approach, PRORELIX RESEARCH recognises that plans can be imperfect and uses data collected during the study to make streaming corrections. Adaptive management provides continuous optimisation of day-to-day study practices analysing and solving the operational issues that could negatively impact enrolment, monitoring and query management — producing substantial cost and time savings. Real-time metrics track key enrolment indicators such as reasons for screen failures or effects of individual inclusion/exclusion criteria. Adaptive management applied to the monitoring process, achieved by real-time site metrics, uses a team approach combining continuous site management and remote monitoring with needs-based allocation of site visits. Sites which are performing poorly (i.e. with low enrolment rate, or higher query rates, or more unresolved queries, or slower query resolution) receive greater attention. Moreover best practices from well-performing sites are quickly identified and shared with non-performing sites. Allocating monitoring resources based on the number of remaining unmonitored fields prevents a lagging site from delaying closeout and database lock for the entire study.

Each aspect of the project is managed with sophisticated and fully customizable Clinical Trial Management System (CTMS). Our systems provide a complete 360° view of the project, supporting accurate and timely decision making by providing critical data in near real-time. The information is available to the client and the PRORELIX research team and permits all to interact with customizable data on every device via secure web-based access.

MEDICAL MONITORING

PRORELIX RESEARCH understands the need of many sponsors to have medically qualified clinical research experts leading various aspects of their clinical research.

The PRORELIX RESEARCH team of medical monitors comprises physicians with many years of industry and appropriate therapeutic experience who are able to provide expert levels of oversight to areas including:

  • Interaction and representation with ASIA,UK,EU and US Regulatory Agencies
  • Clinical Investigation Plan design and writing
  • Subject eligibility verification
  • Clinical Investigation Plan deviations
  • Serious adverse event review and reporting

PHARMACOVIGILANCE

PRORELIX RESEARCH provides accurate and real-time safety management of global drug studies in all phases of clinical research. Our expert Pharmacovigilance team is in constant and direct communication with physicians, CRAs, regulatory authorities, and the client to ensure full control at every stage of the project.

PRORELIX RESEARCH is experienced in addressing the disparate safety reporting requirements in different EU countries, in US, India or other countries.

Our medical monitors are available 24/7 in all time zones in order to address any safety issues as they arise.

Safety reports are managed proactively so that the sponsor and investigator teams are fully invested in any safety decisions made or expedited reports submitted. Experienced PRORELIX RESEARCH medical staff will interface with regulatory authorities (including the FDA) and sponsors to ensure that any safety issues that arise are managed efficiently and pragmatically.

VENDOR MANAGEMENT

PRORELIX RESEARCH is experienced in selecting and managing third party vendors, such as central laboratories, clinical supplies management providers, and IVRS. We take responsibility for selection and management of these vendors, assuring compliance with quality and service deliverables.

Clinical Trial Supplies – With our carefully selected partners or those of our clients, PRORELIX RESEARCH ensures efficient, effective and accountable distribution and subsequent return or destruction of investigational and any comparator devices.

PRORELIX RESEARCH can also oversee packaging, labelling and storage of products. Through our years of experience in clinical research we are experts in the import and export requirements of authorities across the globe and provision of real-time resolution of issues.

Central Laboratories – PRORELIX RESEARCH has extensive experience in working with providers of central laboratory services including biological sample laboratories, centralized diagnostic providers, central respiratory laboratories, and others.

Operational Supplies – Shipment and collection of a variety of other supplies is a central aspect to most clinical trials. This may include interactive response systems, study documentation, copies of images, and technical equipment, among others. PRORELIX RESEARCH supports storage and effective distribution of supplies for all studies.

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