Feasibility: (Assured Timely Enrollment)

ProRelix Research believes that a 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. The more informed and better engineered clinical trials are, the more likely they will stay within budget and be on time. This is why we offer comprehensive feasibility studies as a component of full-service trials and also as a feasibility consulting offering. Our goal is to save you time and costs in the long run. At ProRelixResearch, we draw on our knowledge base of vast clinical research experience, site relationships, regulatory considerations, and industry catalysts to provide a level of insight that is not attainable using traditional feasibility assessments. While for some, feasibility assessments are synonymous with querying investigators and facilitating questionnaires, you can expect a more expansive and critical view of the clinical research environment from our feasibility analysis.

Our feasibility study services are customized to meet your specific clinical trial needs and include:

• Protocol review and design analysis
• Site profile analysis
• Site and patient motivation assessment
• Competitive landscape analysis
• Feasibility data analysis
• Screening and enrolment rate analysis
• Geographic optimization analysis

For help mitigating the risk and optimizing the success of your clinical trial, contact us today.

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, Europe, Australia and USA Regulatory Agencies
• Clinical Investigation Plan design and writing
• Subject eligibility verification
• Clinical Investigation Plan deviations
• Serious adverse event review and reporting

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 Guarantee, 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 personalized 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 organizational 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 on the best solution.

Adaptive Project Management

Using this approach, ProRelix Research recognizes that plans can be imperfect and uses data collected during the study to make streaming corrections. Adaptive management provides continuous optimization of day-to-day study practices analyzing 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 that 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 a 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.

ProRelix Research has successfully managed complex projects in multiple therapeutic areas and is proud to have supported small to medium size companies. In addition, our specialized expertise in working with emerging pharma, biotech, and device companies helps us guide them through the clinical development process.

Our Project Managers collaborate with you from the start to ensure every aspect of a project is planned for and executed precisely. Our project management methodology incorporates standardized processes and metrics for reviewing project progression, risk assessment mitigation, and completion. Our goal is to complete every project on time and on budget while maintaining the high-quality product for which we are known.

Our project management team handles all requirements

Our full-service capabilities allow us to handle an entire program or the services specifically needed by our clients, from protocol strategy to regulatory submission and post-marketing. Our project management responsibilities include:

• Primary Liaison with Clients
• Team Management (Internal and External)
• Timeline Management
• Budget Management
• Project Status Reporting
• Risk Mitigation/Management
• Vendor Management

What we say is what we do

Perhaps our most important differentiator of all, we deliver what we promise. We are accessible – any time, any level, anyone. We offer you direct access to our executive, senior management, and project teams. Transparency in projects is a critical component of our partnership.

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 ongoing 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.

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

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 the 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, labeling, 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 the storage and effective distribution of supplies for all studies.

Clinical Safety Services

Safety is imperative in clinical trials – new drugs and devices, no matter how innovative, cannot get to market unless proven to be safe for those who will use them.

Our Safety Surveillance team provides customized solutions to pharmaceutical, biotechnology, and medical device companies to effectively track and manage their products’ benefits and risks throughout the product lifecycle. We can provide our clients with end-to-end clinical safety services from early phase through approval and post-marketing in 2 ways:

• As part of a full-service project
• As discrete, standalone offerings.

Experienced Staff Provides Clinical Safety Expertise

With expertise across multiple therapeutic areas, our safety staffs of highly trained professionals (including MDs, PharmDs, and RNs) is well versed in safety reporting practices and regulations. Our flexible infrastructure allows us to adapt to your specific safety needs, from case processing and medical evaluation to submission of safety data to regulatory authorities. Sponsors select the level of involvement in the clinical safety process suitable for your company and available resources.

Efficient Technology Enhances Your Study’s Performance

ProRelixResearch utilizes advanced software solutions for its safety database technology platform: Argus Safety and Argus Interchange. ProRelixResearch can offer Argus Safety as well as migrate safety data from legacy or discontinued systems.

We also utilize a validated, industry-accepted electronic gateway, an Interchange platform, in conjunction Safety with Argus. These technologies support safety surveillance for drugs, biologics, vaccines, and medical devices throughout the product’s lifecycle offering:

• State-of-the-art technology backbone with a clean interface, strong redundancy and an efficient configurable workflow to support evolving client needs – used for full-service projects
• Argus Safety database allows hosting for clients who do not have their own safety database and technology infrastructure
• Our system facilitates the secure submission of regulated data, such as individual expedited safety reports (ICSRs/SUSARs), to the FDA and health authorities in standardized ICH formats

In addition, such technology allows for the rapid exchange of safety data among marketing partners, affiliates, and/or vendors while ensuring the integrity of the data. You will have timely access to your data.

Safety Surveillance Services Are Tailored To Your Specific Needs And Include:

• Safety Surveillance support for standalone contracts as well as full service
• Product safety consulting (clinical and post-approval)

For a full overview of our suite of full-service and standalone safety surveillance services, contact us today to speak to our safety services experts so they can answer any questions you might have.

Clinical operations

Clinical operations are a critical component in all studies. From start-up to close-out, our highly skilled clinical operations teams ensure proper planning, conduct, patient safety, and data quality, while fostering good communication between study sites and sponsors.

Our clinical trial managers provide leadership and operational expertise through collaborative planning, implementation, and execution. Clinical research associates work closely with your team on protocol and indication training, building strong site relationships, and ensuring site compliance. Finally, our wide network of clinical trial experts throughout India, and alliances with long-established partners in Europe, USA, and, South Africa, Australia, ensures global consistency, support, and a high standard of quality, meeting ICH-GCP guidelines, wherever in the world we manage your clinical trials.

Whether helping with an overload of work or designing a full-service clinical program, our experienced, knowledgeable team is ready to partner with you to develop a program customized to your needs.

Clinical operations services include:

• Worldwide feasibility studies
• Study start-up including site identification, qualification, and selection
• Study document development
• Essential document collection and maintenance
• Translations
• Trial Master File set-up and maintenance
• Site monitoring and management
• Patient recruitment and retention strategies
• Clinical trial management system
• Training of clinical associates
• CRA management and quality control
• Audit preparation
• IRB/EC submissions
• Third-party vendor management

We’re your best partner. Our goal is to provide you with the services that best meet your needs, and responsible trial monitoring handled by experts. Tell us your challenges – we’ll help you determine your best course of action.

When selecting sites, whether from our database or not, our team take great care to ensure the sites chosen can provide the appropriate services in line the requirements for a particular study.

Our study co-ordinators have a clear focus on enabling a consolidated study duration through exceptional site performance, compliance and quality. Our holistic, flexible custom designed approach increases efficiency and promotes a balanced partnership between the clinical trial process and patient management.

We understand the critical importance to our clients of these site relationships, therefore we expend much time and effort to form lasting relationships right from study start up to study close out, working together with our study sites to meet enrolment targets and deadlines.

We add a personal touch by creating a unique identity for every study that will resonate with site staff and patients alike.

We create a patient-centric approach and deploy a myriad of recruitment methods and tools to overcome enrolment challenges. A combination of cutting edge media resources, dynamic patient education material and maintenance of effective communication with investigative site staff, all mitigate against the key barriers to delivering a study successfully