# Clinexel


## Posts

- [The Next Phase of Cell & Gene Therapy: Understanding the Evolving Regulatory Landscape](https://clinexel.com/the-next-phase-of-fda-approved-cell-and-gene-therapy/): Cell and Gene Therapy Regulatory Landscape has evolved significantly over the past decade—from an emerging field requiring extensive regulatory caution to a maturing therapeutic modality supported by growing clinical, manufacturing, and regulatory experience. As cell and gene therapy (CGT) continues to advance, the regulatory approach is also evolving. Regulators and developers now have access to a substantially larger body of evidence relating to genetically modified cells, vector platforms, manufacturing processes, potency, genome editing, long-term safety, clinical endpoints, and post-approval experience. The challenge is therefore no longer simply determining how cell and gene therapies should be regulated, but how regulation can incorporate […]
- [Oncology Clinical Trials in India: Expanding Opportunities for Early- and Late-Phase Research](https://clinexel.com/oncology-clinical-trials-in-india/): INTRODUCTION India is rapidly establishing itself as a global destination for oncology clinical trials. With a population of 1.4 billion, a growing cancer burden, diverse patient populations, experienced investigators, and evolving regulatory frameworks, the country offers substantial opportunities for both early-phase and late-phase oncology studies. Over the last two decades, India has transformed by developing good clinical sites, proving data of global GCP standards, and great potential for a patient recruitment destination and partner in global oncology multiregional clinical trials and clinical development. Pharmaceutical companies, biotechnology firms, and contract research organizations (CROs) are increasingly leveraging India’s clinical research ecosystem to accelerate […]
- [Navigating the Regulatory Landscape for Clinical Trials in India](https://clinexel.com/clinical-trial-regulations-in-india/): Introduction: Understanding Clinical Trial Regulations in India When the CLINEXEL team attends international conferences, we receive a lot of queries from Clinical Trial Leaders, particularly from emerging biotech companies, regarding the clinical trial environment in India, regulatory timelines, approval processes, operational challenges, and key strategic considerations. This article provides an overview of the evolving regulatory landscape for clinical trials in India, including recent regulatory updates, common challenges, and practical strategies for global sponsors navigating the Indian market. Why India Matters in Global Clinical Trials India has become an increasingly important destination for global clinical trials. Its large and diverse patient population, […]
- [Role of India in Rescue Trials for Accelerating Clinical Development When Timelines Are at Risk: A Perspective by CLINEXEL-AICROS](https://clinexel.com/indias-role-in-rescue-trials-for-clinical-development/): Introduction: When Clinical Trials Need a Course Correction Clinical trials rarely proceed exactly as planned. Despite rigorous feasibility assessments, protocol optimization, and careful site selection, studies can still face unexpected delays. Slow patient recruitment, high screen failure rates, operational inefficiencies, or increased competition from parallel trials can derail timelines. In such situations, sponsors often initiate what are commonly referred to as rescue trials or rescue strategies; targeted interventions designed to recover lost time and restore study momentum. Rescue trials are not merely reactive measures; they are strategic decisions that can determine whether a development program succeeds or fails. One of the […]
- [India’s Strategic Role in Multi-Regional Clinical Trials (MRCTs): A Balanced Approach to Global Clinical Development](https://clinexel.com/indias-role-in-multi-regional-clinical-trials-mrcts/): Introduction to India’s Role in Multi-Regional Clinical Trials (MRCTs) and Global Clinical Development As multi-regional clinical trials (MRCTs) continue to shape modern drug development, sponsors must design studies that are globally relevant, operationally efficient, and regulatorily robust. In this evolving landscape, India has emerged as a key contributor in global clinical trials and MRCT strategies. Its growing role reflects advancements in clinical research in India, strong investigator networks, and improving regulatory processes.India’s role is like a strategic component, that must be thoughtfully integrated into a broader global trial design.   Global regulators such as the U.S. Food and Drug Administration and […]
- [CLINEXEL – AICROS: How to Select Countries for a Multi-Regional Clinical Trial (MRCT): A Strategic Guide](https://clinexel.com/top-cros-in-india-mrct-country-selection-guide/): Introduction: The global clinical development landscape is undergoing a period of recalibration. Rising trial costs, constrained funding environments, and persistent macroeconomic pressures such as inflation are forcing sponsors to rethink how and where they conduct studies. These pressures are not abstract; they translate directly into slower development timelines, delayed decision-making, and increased risk for sponsors. At the same time, the urgency for new therapies has not diminished. In this evolving landscape, Contract Research Organizations in India and globally play a critical role in enabling efficient clinical development. As sponsors increasingly explore multi-regional clinical trials (MRCTs), selecting the right countries and partnering […]
- [Database Lock in Clinical Trials: Top Data Management Mistakes & Clinexel Solutions](https://clinexel.com/database-lock-in-clinical-trials-top-10-mistakes/): What is Database Lock in Clinical Trials and Why It Matters In clinical trials, Database lock in clinical trials is the final and most critical step in the clinical data lifecycle, where all collected data is cleaned, verified, reconciled, and finalized before statistical analysis and regulatory submission.   Delays in the clinical trial database lock process are among the most common and costly issues in clinical development. These database lock delays in clinical trials can directly impact submission timelines, increase operational costs, and delay product approvals. 👉 Key Insight: Most delays are not due to trial complexity—but due to clinical trial data […]
- [Why Include India in Global Clinical Trials: Benefits, Regulations & CRO Insights.](https://clinexel.com/global-clinical-trials-in-india-benefits-cro-insights/): Pharma companies planning to conduct global clinical trials in India often have questions about the approval process and regulatory requirements. In addition, many sponsors seek to understand the advantages of including India in global clinical trials, such as access to a large and diverse patient population, experienced investigators, and cost efficiencies. Before outsourcing clinical trials in India to Contract Research Organizations in India, it is therefore important to have a clear understanding of the regulatory framework and operational landscape in India. To address these needs, we have compiled a list of common questions frequently raised by industry stakeholders exploring clinical trials […]
- [Clinical Trial Regulatory Framework in India: Complete Guide (NDCTR & CDSCO)](https://clinexel.com/clinical-trial-regulatory-framework-in-india/): Introduction Companies planning to conduct clinical trials in India often have queries regarding the clinical trial approval process in India and the overall regulatory pathway. Before outsourcing clinical trials to Contract Research Organizations in India, it is essential to understand the clinical trial regulatory framework in India and how different regulatory components interact. India has evolved into a structured and globally aligned clinical research destination, supported by clearly defined clinical research regulations in India. These regulations ensure that trials are conducted ethically, efficiently, and in compliance with international standards. To simplify this complex landscape, this guide answers the most common industry […]
- [Antimicrobial Clinical Trials in India: Opportunities, Scientific Strengths, and the Way Forward](https://clinexel.com/antimicrobial-clinical-trials-in-india-opportunities-scientific-strengths-and-the-way-forward/): Introduction Antimicrobial clinical trials in India are becoming increasingly critical in the global fight against antimicrobial resistance (AMR). With rising resistance rates and a high infectious disease burden, India presents a unique opportunity to accelerate antimicrobial resistance clinical research while generating globally relevant data. Globally, nearly 30% of bacterial infections show resistance to commonly used antibiotics. In India, this incidence is significantly higher, making AMR clinical trials in India not just relevant but essential. At the same time, innovation in antimicrobials remains financially challenging, often driven by emerging biotech companies rather than large pharmaceutical firms. For sponsors seeking efficient, scientifically rigorous […]
- [CDSCO New Drugs and Clinical Trials (Amendment) Rules, 2026: A Major Step Towards Streamlining Clinical Research in India](https://clinexel.com/cdsco-new-drugs-and-clinical-trials-amendment-rules-2026-a-major-step-towards-streamlining-clinical-research-in-india/): Introduction In January 2026, The Ministry of Health and Family Welfare of India notified the New Drugs and Clinical Trials (Amendment) Rules, 2026, introducing important refinements to the New Drugs and Clinical Trials (NDCT) Rules, 2019. These amendments reflect India’s continued commitment to strengthening its clinical research ecosystem while improving regulatory efficiency. As a full-service CRO, CLINEXEL works closely with global sponsors and partners, supporting clinical development programs both in India and across international markets. We appreciate this regulatory move, which enhances predictability, accelerates study start-up timelines, and reinforces India’s position as a competitive destination for clinical research. The changes are […]
- [Contract Research Organizations in India: How to Pick the Right CRO?](https://clinexel.com/contract-research-organizations-in-india-right-cro/): Planning to Conduct Clinical Trials in India?  A Quick Regulatory Checklist and CRO Assessment Guide  The global clinical research market has been evolving rapidly, with sponsors increasingly outsourcing key development activities to Clinical Research Organizations (CROs). India has emerged as one of the most attractive destinations for clinical research outsourcing due to its diverse patient population, growing regulatory clarity, and cost advantages. Over the last decade,  Indian CROs have expanded their service offerings; however, there are very few CROs that understand the global landscape, have experience working in cross-cultural environments in collaboration with global teams. In India, companies can conduct clinical […]
- [8 Effective Guidelines for Clinical Trials in India: From Submission to Approval](https://clinexel.com/8-effective-guidelines-for-clinical-trials-in-india/): Regulatory Pathway for Clinical Trials in India: From Submission to Approval “Navigating India’s clinical trial regulatory landscape demands precision, expertise, and strategic foresight. At CLINEXEL, we turn regulatory complexity into a clear, compliant pathway to approval”, mentions Dr. Deepa Arora, Founder, Director and CEO of CLINEXEL. India has rapidly positioned itself as a global hub for clinical trials, offering cost advantages, diverse patient populations, and a highly skilled medical workforce. With the implementation of the New Drugs and Clinical Trials Rules (NDCTR), 2019, the country has established a transparent and time-bound Guidelines for clinical trials in India. These rules have brought […]
- [Why Include India in Global Clinical Trials? Key Advantages for Pharma and Biotech](https://clinexel.com/clinical-trials-in-india-great-opportunity-for-pharma/): Introduction Global clinical trials (GCT) have become the backbone of modern drug development. With regulators demanding diverse patient populations and real-world data, sponsors are increasingly turning to geographies beyond North America and Europe. India, with its unique advantages, has emerged as a strategic hub for global clinical research. From a large treatment-naïve population and a wide range of diseases to cost efficiencies and robust investigator networks, the country offers compelling reasons for inclusion in international drug development programs. For sponsors looking to expand, clinical trials in India offer both speed and scale. This article provides a practical, evidence-based overview of why […]
- [Regulatory Framework in India for Clinical Trials: Important Regulations and Compliance Overview](https://clinexel.com/regulatory-framework-in-india-regulations-compliance/): Introduction The regulatory framework in India has evolved rapidly over the past decade, becoming more structured, transparent, and aligned with global standards.  Dr. Deepa Arora, Founder, Director, and CEO of CLINEXEL explains, “Indian regulatory structure is akin to that of the USA. Like the USFDA, CDSCO is the single CLA in India responsible for clinical trial approvals across India.” Through this article, we provide an overview of the key authorities, rules, ethics oversight, and practical tips to help pharma, biotech, and medical device companies navigate the regulatory framework in India with confidence. Regulatory Authorities in India The following entities collectively maintain […]
- [Conducting Clinical Trials in India: The Pharma Industries Next Big Advantage](https://clinexel.com/conducting-clinical-trials-in-india-pharma-industry/): Introduction India is emerging as a strategic hub for high-quality, diverse, and globally relevant clinical trials. With a population exceeding 1.4 billion and a disease spectrum that mirrors global health challenges, the country offers unparalleled opportunities for pharmaceutical companies looking to advance drug development efficiently and effectively.  Poor recruitment rate in clinical trials is a double-edged sword, as it not only delays the trial completion, but trial costs also increase substantially due to increased timelines. Many sponsors initially plan trials in the US or EU, where numerous competing studies often make patient enrollment even more difficult. There is a huge burden […]
- [Selective Safety Data Collection in Clinical Trials: Aligning with ICH E19 Guidelines](https://clinexel.com/selective-safety-data-collection-ich-e19-guidelines/): Introduction As the pharmaceutical industry embraces smarter, leaner, and more patient-centric approaches to clinical development, Selective Safety Data Collection (SSDC) has emerged as a pivotal strategy for improving the efficiency of late-stage and post-approval trials. In particular, the harmonization led by the International Council for Harmonisation (ICH) through the E19 guideline, in alignment with foundational principles in ICH E3 clinical study reports, marks a major evolution in how sponsors can optimize safety data collection without compromising regulatory rigor or patient welfare. This blog delves into what (Selective Safety Data Collection) SSDC is, why it matters, and how it aligns with ICH […]
- [Medical Monitor in Clinical Trials: Essential Roles & Best Practices](https://clinexel.com/medical-monitor-in-clinical-trials-india/): An Expert Perspective on Medical Monitor in Clinical Trials In the realm of clinical development, patient safety and efficiency are of utmost importance. A medical monitor in clinical trials plays a pivotal role across the clinical trial, starting from designing the study until clinical study report. Ongoing review of data by medical monitors in clinical trials not only enhances the quality of clinical research but also guarantees that the well-being of participants remains at the forefront of all procedures. This blog delves into the core responsibilities of medical monitors, the evolution of their role, and how medical monitoring is integral to […]
- [Clinical Trials in Oncology: Planning and Conducting Multi-Regional Clinical Trials](https://clinexel.com/clinical-trials-in-oncology-planning-and-conducting-multi-regional-clinical-trials/): In September 2024, the U.S. Food and Drug Administration (FDA) introduced a pivotal guidance document titled “Considerations for Generating Clinical Evidence from (MRCTs) Multi-Regional Clinical Trials in Oncology.” This guidance serves as a comprehensive roadmap for optimizing drug dosages in oncology trials and outlines strategies for effectively planning, designing, and executing MRCTs in cancer research. The aim is to enhance the rigor of MRCTs in generating robust clinical evidence, supporting faster and more equitable access to life-saving therapies. This blog delves into the key aspects of the FDA guidance and highlights how the Clinexel team’s expertise aids in designing and conducting […]
- [US FDA Guidance on Dose Optimization for Oncology Drugs -Clinical Pharmacokinetic considerations](https://clinexel.com/us-fda-guidance-on-dose-optimization-for-oncology-drugs-clinical-pharmacokinetic-considerations/): The FDA guidance on dose optimization for oncology drugs has introduced a pivotal framework aimed at refining dose selection in cancer treatments. This guidance emphasizes the importance of clinical pharmacokinetics (PK), population PK analysis, and dose-response relationships to ensure the efficacy and safety of oncology drugs. Importance of Clinical Pharmacokinetics in Dose Selection Clinical pharmacokinetics plays a central role in aligning drug dosages with patient safety and therapeutic outcomes. According to the FDA guidance on dose optimization, all dose levels in oncology trials must be backed by rigorous nonclinical and clinical data, including PK, pharmacodynamics (PD), tumor response, safety, and tolerability. […]
- [Clinexel Appoints Dr. Mukesh Kumar as Chief Scientific Officer](https://clinexel.com/dr-mukesh-kumar-as-chief-scientific-officer-clinexel/): In a significant move to reinforce its leadership team, Clinexel, a full-service Clinical Research Organization (CRO), has appointed Dr. Mukesh Kumar as its Chief Scientific Officer (CSO). With extensive experience leading Clinical Research & Development (RnD) in global pharmaceutical giants such as Sanofi and Daiichi Sankyo, as well as Indian pharmaceutical leaders like Cipla, Dr. Reddy’s Laboratories, and Lupin, Dr. Kumar brings invaluable expertise to Clinexel’s expanding clinical operations. Dr. Mukesh Kumar Clinexel Strengthens Leadership with the Appointment of Dr. Mukesh Kumar as Chief Scientific Officer Enhancing Clinical Research Capabilities Clinexel is renowned for executing high-quality, cost-effective clinical trials across Phases […]

## Pages

- [Expert Insights](https://clinexel.com/expert-insights/): Expert Insights Insights 8 Videos Clinical Trials Explained by a CRO Expert | Bioasia 2026 | Clinexel | Dr. Deepa Arora 2:06 Only 2% of Global Trials in India: Patients Are Missing Out on Early Access to New Cancer Drugs 4:02 Need stronger clinical trial ecosystem to propel India’s oncology innovation: Dr Mukesh Kumar 4:08 Mukesh Kumar on Scaling Clinical Innovation in Indian Pharma | ET RE-Pharma 2026 1:16 India, more than 1.3 billion inhabitants. A good opportunity for clinical trials? 27:55 Dr. Deepa Arora on Clinical Research Prospects | Founder & CEO, ClinExcel Life Sciences 9:10 Ep: 91 How To […]
- [Careers](https://clinexel.com/careers/): Join us in advancing clinical research and making a meaningful impact in global healthcare. At CLINEXEL we are always looking for talented and passionate professionals to join our growing team. We regularly post job opportunities across various functions on our LinkedIn, Facebook, Instagram pages. Follow us to stay updated on the latest openings and career opportunities:   Instagram Facebook Linkedin Youtube X-twitter Open Poistions Clinical Research Associates (CRAs) We are looking for Clinical Research Associates to support the successful execution of clinical trials through site monitoring and management activities. Key Responsibilities:– Conduct site qualification, initiation, monitoring, and close-out visits.– Ensure compliance with […]
- [Shivani Nayak](https://clinexel.com/our-team/shivani-nayak/): Shivani Nayak   Masters in Pharmacy (M. Pharm- New Drug Delivery Systems), PG Diploma in Patent Law   Head- Regulatory Affairs Shivani is a Pharmacist with experience of working with CDSCO (Competent Authority (CA)/ Central Licensing Authority in India) as well as in a pharma company. Due to her unique experience, Shivani understands both sides of the regulatory affairs and has experience in preparation, compilation and review of dossiers for Clinical trial Application, pre-IND, IND and Marketing authorization as well as coordination with CA office during the CA review process.
- [Dr Madhuri V](https://clinexel.com/our-team/dr-madhuri-v/): Dr Madhuri V   Masters in Pharmacy, Ph.D (Pharmaceutical Medicine)   Head- Medical & Safety Writing Dr. Madhuri is a Doctorate with strong knowledge and understanding of clinical research, pharmacovigilance and project management. Dr. Madhuri has wide ranging experience in clinical research organizations and pharma companies. She has good understanding of Good Clinical Practices, Good Vigilance Practices and is well versed with Medical Device Regulations. Dr. Madhuri’s experience spans across therapeutics as well as medical devices in several therapeutic areas.
- [Nandkishor Toraskar](https://clinexel.com/our-team/nandkishor-toraskar/): Nandkishor Toraskar   PGD in Systems Management (DSM I) and Computer Management (DCM)   Head – Clinical Data Management and Biostatistics Mr Toraskar has more than 35 years of experience in clinical data management. He has previously worked with leading companies like Roche, Pfizer, Ranbaxy, Wockhardt and Sun. He served as Head of Clinical Data Management at Ranbaxy and Wockhardt where he was responsible for data management activities across all clinical trials spanning from Phase I, II, III as well as Phase IV clinical trials. His most recent engagement was with Sun Pharma where he was Head of Clinical Data Management […]
- [Nilesh Bhopale](https://clinexel.com/our-team/nilesh-bhopale/): Nilesh Bhopale   Masters in Pharmacy (M. Pharm- Pharmacology)   Head- Clinical Research Nilesh is a Clinical Research Professional with 12+years of experience in clinical trials in Phase 1 to Phase 3 and Postmarketing Clinical trials as well as in Bioequivalence studies. Nilesh has strong understanding of Good Clinical Practices and his experience spans across multiple therapeutic areas. He has previously worked in Pharma companies as well as in clinical research organizations.
- [Dr. Mukesh Kumar](https://clinexel.com/our-team/dr-mukesh-kumar/): Dr. Mukesh Kumar   Chief Scientific Officer Ex- SVP, Global Clinical R&D, – (Dr Reddys Lab, CIPLA)  Clinical Research Director, Global R&D, (Sanofi, Daiichi Sankyo) Physician and clinical pharmacologist (MD) with ~ 25 years of experience in global clinical development Experience- high quality ~200 clinical trials & 1000 BE studies, track record of NO 483 in ~ 80 inspections (FDA, EMA) Solid track record of cost-effective global quality clinical development execution for generic & 505(b)(2) opportunities Contributed in ~ 50 innovative and ~ 150 complex generic products: led clinical, pharmacology (PK-PD) and biopharmaceutic aspects including negotiations for generic and 505 (b)(2) clinical path […]
- [Dr Deepa Arora](https://clinexel.com/our-team/dr-deepa-arora/): Dr Deepa Arora   MBBS , MD   Chief Executive Officer Dr. Deepa Arora is the Chief Executive Officer of CLINEXEL. She is a physician (MBBS, MD) and served in global leadership roles in large pharma-biotech companies. Dr. Arora has 25+ years of experience in Clinical Development and Pharmacovigilance with strong understanding of the regulatory and business needs of regulated and semi-regulated markets. Her vision is to establish CLINEXEL as the preferred partner for pharmabiotech and medical device companies by providing customized, tailormade clinical, pharmacovigilance and regulatory solutions for expediting the clinical development of their innovations. Physician, ~25 years of experience […]
- [Our Team](https://clinexel.com/our-team/): Our Experts WE are a team of committed and talented professionals including pharmaceutical physicians and pharmacists, clinical research professionals, expert clinicians, and medical writers. WE have an extensive 150+ years of cumulative industry experience in handling time-sensitive projects and delivering with high Quality Dr Deepa Arora Chief Executive Officer Know More Dr. Mukesh Kumar Chief Scientific Officer Know More Nilesh Bhopale Head- Clinical Research Know More Dr Madhuri V Head- Medical & Safety Writing Know More Nandkishor Toraskar Head – Clinical Data Management and Biostatistics Know More Shivani Nayak Head- Regulatory Affairs Know More
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- [Biostatistics](https://clinexel.com/clinical-biostatistics/): Biostatistics Our Clinical Biostatistics services provide precise statistical analysis to support clinical research and decision-making. We ensure compliance with regulatory standards for reliable and data-driven outcomes. Talk to Our Experts At Clinexel, our Clinical Biostatistics services provide accurate and reliable statistical support for clinical research. With a team of experienced biostatisticians, we ensure that every study adheres to regulatory guidelines and delivers data-driven insights for informed decision-making. Sample size calculation & inputs for the Protocol Develop Randomization Schedule Statistical Analysis Plan Statistical Analysis Plan Programming, Validation and Generation of TLFs for interim and final analysis Data Import for Statistical Analysis ADaM […]
- [Data Management](https://clinexel.com/data-management-in-clinical-research/): Data Management In Clinical Research Effective data management in clinical research is crucial for ensuring the accuracy, integrity, and compliance of clinical trial data. By implementing robust data collection, validation, and analysis processes, we help streamline research workflows, minimize errors, and maintain regulatory standards, ultimately supporting reliable and high-quality study outcomes. Talk to Our Experts data management in clinical research Data Management Plan – Develop and Maintain Study Set-Up eCRF Development / Screen Test / Release Data Validation Plan Edit Check Implementation / Testing Perform UAT testing Local Lab Range Data System Development EDC Integration with other systems Patient Profile Programming […]
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- [Specialized Safety Services](https://clinexel.com/specialized-safety-services/): Specialized Safety Services Clinexel expert physicians and pharmacists provide Specialized Safety Services including early phase safety and medical monitoring of new therapies, development of integrated safety databases, signal identification and management during clinical development, development and implementation of medical and safety monitoring plans Talk to Our Experts EXPERT SAFETY WRITING SERVICES Preparing Responses to Request for Information (RFI) from Competent Authorities High Quality Narrative Writing Preparing Direct Healthcare Professional (DHCP) Communications Analysis of Similar Events (AoSEs) Benefit Risk Assessment Reports Integrated Safety Summary (ISS) Safety Sections of Clinical Trial Reports Clinical Overview and Clinical Summary Drug Safety in Clinical Development Highly […]
- [Medical Writing](https://clinexel.com/professional-medical-writing-by-industry-experts/): MEDICAL WRITING Drafting high quality Protocols, Informed Consent Forms (ICF), Investigators’ Brochure (IB), Clinical Study Reports (CSR), Clinical Evaluation Plans & Clinical Evaluation Report (CEP, CER) including literature search protocol, PICO analysis, Manuscripts for Publications. Connect with a Medical Writing Expert Today CLINEXEL SERVICES Professional Medical Writing by Industry Experts Benefits of Hiring Professional Medical Writing Experts Essential Documents for Clinical Trials (Protocol, IB, ICD, and CRF) Clinical Study Reports Literature Review & PICO Analysis Clinical Evaluation Plans and Clinical Evaluation Reports Performance Evaluation Plans and Performance Evaluation Reports FAQs, Standard Response Letters, Publications, Fact Sheets CLINEXEL EXPERTISE clinical research writing […]
- [Representative Services](https://clinexel.com/representative-services/): Europe Qualified Person (QP) services EU- Qualifier Person for Pharmacovigilance (EU-QPPV) Pharmacovigilance Services Master File (PSMF) holder- Qualifier Person for Pharmacovigilance (EU-QPPV) Local Safety Officers in the Member States of EU Legal Representative in Europe EU Data Protection Officer India Legal Representative in India Regulatory Agent in India Data Protection Officer in India PvOI (Local Safety Officers) in India and PvMF holder in India US US Agent Rest of the World QPPV services in Africa, Middle East countries and CIS countries Regulatory Agent Support in multiple countries
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- [Pharmacovigilance-3](https://clinexel.com/pharmacovigilance-3/): PHARMACOVIGILANCE OPERATIONS(END TO END PHARMACOVIGILANCE OPERATION SERVICES) CLINEXEL Team Members Have Extensive Experience With GVP And PADE Inspections Conducted By The USFDA, Health Canada, TGA, EMA, MHRA & BfArM. We Are Conducting End To End Pharmacovigilance Operations For Multiple Pharma Companies For The US FDA And India Compliance, Including Case Processing, Periodic Reports, Literature Monitoring, Signal Detection, Preparation Of Risk Management Plans And Evaluation Of Additional Pharmacovigilance Activities And Additional Risk Minimization Measures. Pharmacovigilance Systems Master File (PSMF) Preparation, Authoring And Maintenance Of PSMF QPPv Services  EU-QPPV/ QPPV/ Local Safety Officer Services For EU, CIS Countries, MENA And LATAM  Point Of […]
- [Home](https://clinexel.com/): CLINEXEL – A Full Service Clinical Research Organization Clinexel – Trusted Clinical Research Organization for Full-Service Clinical Trials & Clinical Development We are a full-service clinical research organization that provides end-to-end services for clinical development, clinical operations, regulatory affairs, medical writing, and pharmacovigilance. Our clients include Pharma, Biotech, and Medical Device companies based in India, Europe, the USA, Canada, Israel, and Singapore. CLINEXEL is a full-service Clinical Research Organization (CRO) with presence in India and the USA. We are providing end-to-end services for Clinical Development, Clinical Operations, Regulatory Affairs, Medical Writing, and Pharmacovigilance. CLINEXEL is the partner of choice for innovative, […]
- [Contact us](https://clinexel.com/contact-us/): Contact Us Please fill in the form below to send us your enquiries. Phone +91 7738804988 Email info@clinexel.com Address Office No. 1401, The Affaires, Palm Beach Road Sector 17, Sanpada Navi Mumbai, Maharashtra, India- 400705
- [Global Clinical Development](https://clinexel.com/global-clinical-development-solutions/): Global Clinical Development We provide global clinico-regulatory services to pharmabiotech and medical device companies for the development of new chemical entities, biologicals and medical devices. We strategize, develop dossiers and coordinate for pre-IND and scientific advice meetings to firm up the clinical development plans and regulatory strategies. We are also working on subsequent IND projects for the Life Cycle Management of pharmaceuticals. Talk to Our Expert We Support Companies global clinical development solutions Development of efficient clinical development plans acceptable to different Competent Authorities. Facilitating pre-IND, End of Phase and pre-NDA submission meetings with regulators to develop and fine-tune clinical development […]
- [Regulatory](https://clinexel.com/regulatory/): Regulatory Affairs At CLINEXEL, we provide Clinico-regulatory services including CT dossier preparation & CA approvals, pre-IND dossier preparation & coordination for pre-IND/ scientific advice meetings, IND filing including CC with the Agency. Talk to Our Experts CLINEXEL SERVICES Regulatory Consulting and Strategic Services Preparation of Clinical Development Plan Preparation of pre-IND Meeting Dossier, Facilitating Pre-IND and Scientific advisory meetings Filing Clinical Trial Applications Supplemental NDA / Subsequent IND for Life Cycle Management (new formulations/ indications) Regulatory Compliance and Gap Analysis of IND dossiers for IND filing Package Inserts (PI) -new PI development, Maintenance and Updates CLINEXEL EXPERTISE Strong Knowledge of Regulations- […]
- [Pharmacovigilance](https://clinexel.com/pharmacovigilance-services-provider-in-india/): PHARMACOVIGILANCE At Clinexel, we provide various services including Case Processing, Regulatory Submissions, Aggregate Reports, Literature Monitoring, Signal Detection and Risk Management Plans (RMPs). We conduct GVP audits and provide QPPV services in several countries. Talk to Our Experts Best Pharmacovigilance Services Provider In India – CLINEXEL (End to End Pharmacovigilance Operations) PHARMACOVIGILANCE SYSTEMS MASTER FILE (PSMF) Preparation, Authoring and Maintenance of PSMF The PSMF describes the MAH’s PV system and documents the compliance with the legal requirements in the EU/EEA A PSMF must be kept fully up to date at all times. PSMF to be available within 7 days on-request for […]
- [Pharmacokinetic Studies](https://clinexel.com/pharmacokinetic-studies/): PHARMACOKINETIC STUDIES CLINEXEL Team members have extensive experience in pharmacokinetic studies of healthy volunteers and patients. The cumulative experience of the team spans 800 studies for various markets, including PK studies in healthy volunteers, and patients for Long-Acting Injectables, biosimilars and inhalation products. Our strengths include strong Project Management and Experience in handling time sensitive projects Team members have experience with different formulations including injectables, rectal suppositories, local applications, inhalation, transdermal, nasal sprays, intravaginal tablets and suppositories. Team members experience also includes pharmacokinetic studies in patients for Long Acting Injectables and Oncology drug and pharmacokinetic studies for biosimilars and inhalation products. […]
- [Our Company](https://clinexel.com/our-company/): About Clinexel CLINEXEL is a Private Limited company incorporated in India in January 2019, with head office in Navi Mumbai. Mumbai is the Commercial Capital of India. Our Team includes professionals (physicians, pharmacists, doctorates, graduates and postgraduates in science) with hands on industry experience. CLINEXEL Team is a talented group with shared vision of contributing to the clinical development of safe and effective therapeutics. Learn more about our Experts.Growth of CLINEXEL is a testimony of expertise, dedication and hard work of the CLINEXEL team. We were able to set-up and provide end to end services for Clinical Research and Pharmacovigilance in […]
- [Medical Devices](https://clinexel.com/medical-devices/): Medical Devices CLINEXEL experts have rich experience in medical device and pharma industry. CLINEXEL team has experience with following devices- stents, ventilators, intraocular lens, respiratory devices, orthopaedic devices, electromagnetic radiation emitting devices, sutures and gloves. Connect with a Medical Writing Expert Today CLINEXEL SERVICES Post Marketing Clinical Follow-up (PMCF) studies for marketed devices Pilot clinical trials -investigational devices Pivotal clinical trials for investigational devices Clinical Evaluation Plans and Clinical Evaluation Reports Performance Evaluation Plans and Performance Evaluation Reports Materiovigilance CLINEXEL EXPERTISE Strong knowledge of EU MDR and IVDR Well versed with India Medical Device Rules Good understanding of ICH E6 and […]
- [Clinical Trials](https://clinexel.com/best-clinical-trials-organization/): BEST CLINICAL TRIALS ORGANIZATION CLINEXEL is the Best clinical trials organization offering full-service CRO capabilities with in-house Full-Time Equivalents (FTEs) and qualified vendors providing services from protocol preparation, site selection, regulatory and EC approvals, clinical monitoring, Clinical Data Management (CDM) until Clinical Study Report (CSR) writing. CLINEXEL employees Clinical Research Associates (CRAs), Monitors, Project Managers (PMs), and Medical Writers (MWs) as Full-Time Equivalents (FTEs), working from the Clinexel office. CLINEXEL offers full-service CRO capabilities, providing Clinical Research Services, with in-house Full-Time Equivalents (FTEs) and qualified vendors.  CLINEXEL expertise includes Strong Project Management & High-Quality Clinical Trials Monitoring Services. Team at CLINEXEL […]
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- [Awards And Recognitions](https://clinexel.com/awards-and-recognitions/): Awards and Recognitions At Clinexel, our hard work and consistent delivery of projects with high quality have been recognized through various awards that we have received from time to time. We have been ISO certified for QMS and ISMS since 2020 with annual renewals. A brief overview of our awards is given below ISO 9001:2015:QMS ISO 27001:2022:ISMS Best Pharmaceutical Scientific Support Provider 2019 Company of the year 2020 In 2023, Clinexel has been awarded “Best Full Service CRO Clinical Trials Organisation 2023 – South Asia” by Global Health Pharma In 2024, Clinexel has been awarded “Best Full Service CRO Clinical Trials […]
- [About Us](https://clinexel.com/about-global-clinical-research-organization/): About Us Global Clinical Research Organization CLINEXEL is a full-service Contract Research Organization providing end-to-end services for Global Clinical Development, Clinical Research & Operations,Regulatory Affairs, Medical Writing, Clinical Data Management and Pharmacovigilance. CLINEXEL is an Independent, financially stable CRO with long-standing collaborations with Sponsors & KOLs. Our clients include Pharma, Biotech, and Medical Device companies based in India, Europe, the USA, Canada, Israel, and Singapore. CLINEXEL has Extensive Experience of conducting Clinical Trials of all Phases (Phase I to Phase IV) and First in Human-Clinical Studies and offers end to end clinical trials-services from preparation of Clinical Trial Protocol and Patient […]

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