Capabilities Overview

Regulatory Affairs

From bench-to-bedside is a long, complicated, resource and cost exhaustive journey which every pharmaceutical product has to go through before seeing the light of the market. The complex, tough and diverse regulatory paradigm across the world adds to these challenges.

CliniRx understands these regulatory challenges and provide tailored, product specific regulatory solutions to meet Sponsor expectations with respect to cost, time and quality. CliniRx has highly experienced, and trained regulatory professionals who can collaborate with Sponsor in strategizing a regulatory path for the pharmaceutical product (whether it be drug, biological, medical device or cosmetics). CliniRx’s regulatory knowledge and extensive understanding of regulatory machinery will provide Sponsor a clear perspective of regulations across key geographies and will help to clear any apprehensions.

Regulatory Affairs services at CliniRx include:

  • eCTD Regulatory Dossier Preparation, Publishing and Submission
  • Global Regulatory and Scientific Advice strategies preparation, meeting and execution at all stages of development
  • Program review (including pre-clinical, pharmacology, CMC and clinical elements)
  • Regulatory management through full product life cycle
  • Regulatory strategy and agency communication to obtain first-cycle approvals

Consulting: Planning and strategy are key to success and CliniRx regulatory personnel are experienced in providing customer/product specific regulatory solutions which will meet Sponsor expectations in terms of cost, time and quality.

Local Applicant Support: CliniRx provides local regulatory support in key geographies. To conduct a clinical trial, Sponsors have to collaborate with a legal, registered entity in that geography. This is not just an administrative support and entails responsibilities and accountabilities. We as a team are fully prepared to take these responsibilities and accountabilities.

Filling Regulatory Applications: Quality output is only possible with a quality input. CliniRx understands and applies this concept in every aspect of its process driven services.

CliniRx has trained and experienced team who supports in compiling the technical dossier, conduct quality check and submits to the regulatory agency. Liasioning with regulatory agency post submission to expedite review and approval process is key. A combination team including medical and regulatory experts supports Regulatory Meetings.

County specific Registration: CliniRx supports registration to the country specific national website, such as,

Post-Approval Maintenance: It involves various submissions like protocol amendments (substantial & non-substantial), IB amendments, Change of site/PI, DSUR & PSUR submission, registration and license renewal etc. CliniRx being the partner organization will support Sponsor with end to end solution.

Safety Reporting: Safety Reporting (Expedited, Periodic reporting, ) is undertaken in key geographies in the world.

  • Eudravigilance
  • MHRA
  • FDA
  • TGA

Strategic Consulting

The highly experienced team at CliniRx helps our global clients in reducing overall trial costs while maximising the reach and output with our strategic consulting services.

Project Management

CliniRx’s highly experienced and outcome-focused project management professionals help Sponsor navigate efficiently through the clinical development program.

Our unique preferred-partner model provides access to a proficient, receptive and result-oriented project team, guided by robust and reliable processes that comply with global regulatory standards.

CliniRx offers a range of Project Management Services:

  • Site Identification, Feasibility and Selection
  • Regulatory and Ethics Committee submissions
  • Project Management and monitoring of clinical development programs (Phase I-IV trials)
  • Patient recruitment strategies
  • Third party vendor management

CliniRx professionals are equipped to provide Sponsor with a comprehensive and unmatched support at all stages of the clinical development programme.

Vendor Management

Whether it needs to on-board new vendors or manage existing vendors for a study – CliniRx offers the best technological and operational support in identifying the vendors adding value from cost perspective, adherence to timelines and reliability.

With CliniRx, you can be sure of working with the best-in-class vendors that provide efficient, proactive and cost effective services.

What we do for you:

  • Rapid identification, evaluation and qualification of vendors
  • Achieve best value agreement
  • Optimize savings opportunities with effective spend management
  • Ensure Vendor compliance and oversight throughout project lifecycle
  • Ensure transparency in vendor management policy

Our professionals are equipped to provide you with a comprehensive and unmatched support at all stages of your clinical development programme.

Quality Assurance

CliniRx is a quality driven organization with well documented quality management system (QMS). We believe that quality starts within the organization by establishing a quality culture in which employees “live” quality in all their actions. Our quality assurance experts are highly trained, experienced and competent. Our approach to quality is one that demonstrates our commitment towards meeting or exceeding your expectations. Once awarded a project we will make sure that quality is built into the project from the day one.

Our flexible organizational structure where quality assurance can operate independently, peoples approach to quality, effective communication, knowhow of global standards, and proactive solutions, make us unique and helps to be leader in the clinical research quality assurance service domain.

Our Quality Assurance Services Include:

  • Project Specific Quality Compliance Assessments. Involves review of essential documents, regulatory green signal process, vendor due diligence, TMF assessments, clinical trial site assessments, process level assessments etc.
  • Good Clinical Practice (GCP)/Compliance Audits. We offer following types of audits- investigator site, vendor, trial master file, database, document, pharmacovigilance, labs, institutional review board or ethics committee and Good Manufacturing Process (GMP). We also undertake effectiveness audits of QMS, training programs and Corrective Action & Preventive Actions (CAPA).
  • SOP/WI, forms and templates development for various stakeholders like Site Management Organization (SMO), Contract Research Organization (CRO), Sponsor, Clinical Trial Sites and Ethics Committees.
  • Preparation of Sponsor/CRO/SMO, clinical trial sites and other vendors for regulatory inspection or independent audits.
  • Quality Assurance Trainings for all stakeholders (e.g. vendors, clinical trial sites, ethics committees, sponsor personnel etc.)

Our Excellence Factors:

Customer Focused
Employee Empowerment
Well Documented QMS
Internal and External Assessments, and Process Control
Employee Trainings
Effective CAPA
Compliance with Global Standards
Effective Communication
Leadership Drives the Quality Culture
Continuous Improvement

Clinical Monitoring

Team meticulously selects CRAs based on their experience in appropriate therapeutic area.

A strong training program then sets base for the interface between the project team and the Investigator, where CRAs demonstrate high levels of site management skills to ensure that issues at sites are addressed quickly and completely, allowing sites to work efficiently and maximize data quality.

Strategically located regional CRAs ensure local knowledge, language, and cultural understanding, as well as to reduce travel costs and increase efficiency.

Clinical Operations team takes training on priority, thus, specific and personalized training program runs throughout the year. This results quality CRAs assigned to a study.

Drug Safety and Pharmacovigilance

CliniRx undertakes to provide and oversee comprehensive drug safety, medical information services, medical writing and risk management programs.

Through preferred partner, CliniRx provides the safety database, aggregate reporting and complete clinical safety and medical writing services.

CliniRx believes its experienced personnel will be able to assist not only as a service provider but also as an extension of your current team.

A complete hosted and fully validated ARGUS Safety database, compliant with 21 CFR Part 11 and EU GMP 5 Regulations, can be provided.

The systems will be accessible to Sponsor, if needed, via VPN protected by layers of firewall.

A team of expert medical physicians assist in writing a complete Clinical Study Report (CSR).

CliniRx team has years of experience in generation and submission of safety reports globally. CliniRx team is capable of creating the complete report or sections of:

  • Periodic Benefit – Risk Evaluation Report (PBRER),
  • Periodic Safety Update Reports (PSUR) if not moved to PBRER,
  • Development Safety Update Reports (DSUR), and Periodic Adverse Drug Experience Reports (PADERs) in the US,
  • Summary Bridging Reports (SBRs) and
  • PSUR Addendum Reports (ARs).

Medical Monitoring

Medical Monitoring is an integral part of the Medical Affairs team at CliniRx. All medicos working at CliniRx are MDs, providing highest quality of proficient services and work with sites to ensure quality medical data.

Services offered:

Before the Study

  • Study Document (e.g. Protocol, IB) review
  • Site Selection in collaboration with Clinical Operations team
  • Protocol Training across functions and teams

During the Study

  • Patient Eligibility Review/Assessment
  • Tracking and resolution of Medical related issues, data listings
  • Tracking and resolution of safety and efficacy data
  • SAE Management
  • On-Site Medical monitoring
  • Review coding

After the Study

  • Review CSR
  • Review Coding
  • Review efficacy and safety listings

Medical Writing

Study Document (e.g. Protocol, IB) Designing Clinical Study Report writing

Data Management & Biostatistics

CliniRx has an extensive experience in collecting, storing; analyzing, interpreting and presenting clinical data. Our in-house clinical data management experts are committed to upholding a standardized, process-driven approach by using the state-of-the-art tools such as Medidata, INFORM, etc. Our experienced biostatisticians are able to demonstrate efficacy of a drug or a medical device and present results in the clearest way possible. CliniRx complies with ICH/GCP, CFR PART 11, GDPR, and other data protection guidelines.

Key services are:

1. Clinical Data Management

The team utilizes latest technology and platform to provide these services, that include:

  • Data Management Plan and Data Validation Plan
  • eCRF/CRF Designing
  • Lab Data Transfer Guidelines
  • Database Designing
  • Database Testing and User Acceptance Testing
  • Medical Coding & Drug Coding
  • SAE Reconciliation
  • Data Migration
  • Data Upload: LIMS to Database
  • Data Review and Query Management
  • Help Desk Support for sites etc

2. Biostatistics: CliniRx can provide experienced statisticians to offer a range of Biostatistics services.

3. Statistical Programming & Analysis (using SAS 9.4)

4. Development of Custom Data Management Tools

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