Submission-ready datasets aligned with global regulatory standards.

Intro
CDISC Implementation

At Clinnex, we ensure that your clinical data is structured, standardized, and fully compliant with global submission requirements.

At Clinnex, we ensure that your clinical data is structured, standardized, and fully compliant with global submission requirements.

Our CDISC implementation services enable seamless data integration, traceability, and regulatory readiness - helping sponsors accelerate approvals with confidence.

By combining domain expertise with robust validation processes, we deliver datasets that are consistent, transparent, and ready for submission across regulatory agencies.

Intro
CDISC Implementation

At Clinnex, we ensure that your clinical data is structured, standardized, and fully compliant with global submission requirements.

At Clinnex, we ensure that your clinical data is structured, standardized, and fully compliant with global submission requirements.

Our CDISC implementation services enable seamless data integration, traceability, and regulatory readiness - helping sponsors accelerate approvals with confidence.

By combining domain expertise with robust validation processes, we deliver datasets that are consistent, transparent, and ready for submission across regulatory agencies.

Key Capabilities

We structure and validate clinical data in line with CDISC standards to ensure seamless integration and regulatory readiness.

Our capabilities enable traceable, compliant datasets that support efficient global submissions.

Developing standardized datasets and metadata aligned with CDISC guidelines to support accurate analysis and submission. 

Ensuring end-to-end traceability from raw data to analysis datasets through rigorous validation and documentation.  

Preparing submission-ready packages compliant with regulatory expectations, including support for data review and queries.  

Key Capabilities

We structure and validate clinical data in line with CDISC standards to ensure seamless integration and regulatory readiness.

Our capabilities enable traceable, compliant datasets that support efficient global submissions.

Developing standardized datasets and metadata aligned with CDISC guidelines to support accurate analysis and submission. 

Ensuring end-to-end traceability from raw data to analysis datasets through rigorous validation and documentation.  

Preparing submission-ready packages compliant with regulatory expectations, including support for data review and queries.  

Our Approach

We adopt a structured and quality-driven approach to CDISC implementation - ensuring consistency across datasets, adherence to standards, and readiness for regulatory review. Our teams work closely with data management and biostatistics functions to maintain alignment and eliminate downstream discrepancies. With a strong focus on validation and traceability, we ensure that every dataset stands up to regulatory scrutiny.

Value We Deliver

Streamlined submission processes and enhanced regulatory compliance.

Streamlined submission processes and enhanced regulatory compliance.

By delivering standardized, validated, and traceable datasets, we help reduce submission timelines, minimize queries, and improve overall efficiency in regulatory approvals.

Value We Deliver

Streamlined submission processes and enhanced regulatory compliance.

By delivering standardized, validated, and traceable datasets, we help reduce submission timelines, minimize queries, and improve overall efficiency in regulatory approvals.

Partner with us for efficient, compliant, and insightful clinical research solutions.

Contact Us

Partner with us for efficient, compliant, and insightful clinical research solutions.

Contact Us

Rituja

Director – Business Development, Asia Pacific

Rituja Doiphode serves as Director – Business Development, Asia Pacific at Clinnex, bringing over 18 years of experience in clinical research and pharmaceutical development. She has extensive expertise in business development, strategic planning, client relationship management, and market expansion across the pharmaceutical, biotechnology, and healthcare sectors.


Throughout her career, Rituja has successfully led initiatives focused on new business generation, strategic partnerships, account management, contract negotiations, and business growth. Her experience spans both Indian and international markets, where she has worked closely with clients and stakeholders to develop value-driven collaborations and support the advancement of innovative healthcare solutions.


A strong advocate of strategic thinking and operational excellence, Rituja has built and mentored high-performing teams, established robust business processes, and consistently driven organizational growth through innovative and customer-centric approaches.


At Clinnex, she is responsible for leading business development activities across the Asia Pacific region, strengthening client partnerships, identifying growth opportunities, and supporting the company’s mission of delivering high-quality clinical research solutions to pharmaceutical, biotechnology, and medical device organizations.

David Ignatius​

HEAD – BIOMETRICS

With over 30 years of experience in Clinical Data Management, Biostatistics and project management.

 

Worked with global contract research organizations (CROs) to successfully lead multiple complex studies.

 

Effectively managing resources and optimizing team performance while ensuring high-quality data collection and analysis.

Dr. Sarita Dimri

DIRECTOR – CLINICAL AFFAIRS AND PATIENT SAFETY

A medical and safety professional with over 18 years of multifaceted experience across dermatology, pharmacovigilance, clinical research, medical monitoring, and medical affairs.

 

Specialized in global safety management, including signal detection, risk mitigation, regulatory compliance, aggregate safety reporting, and clinical research support across diverse therapeutic areas.

Parvathi Chandrasekar

DIRECTOR – PROJECT MANAGEMENT

Over 23 years of work experience in the healthcare industry in India and US including 19 years in Clinical project & portfolio management. Experienced working with CRO, Pharmaceutical companies, academic & research organizations and NGOs.

 

By education, holds a Bachelor’s degree in Pharmacy and a Masters in Public health.

 

Experienced in managing large global studies across multiple therapeutic areas including Oncology (early drug Development), Neurology, Psychiatry, Cardiovascular and Infectious diseases across Preclinical, Phase 1, 2, 3 and 4 studies. Expert in managing multiple vendors, complex studies and cross functional teams.

Dr. Ashoka K Singh

HEAD – MEDICAL

Over 30 years of industry experience including 25 years of experience in Clinical Research.

 

Worked in Major CROs in Clinical Operations and Medical Monitoring.

 

Expertise in Therapeutic areas such as Oncology, Psychiatry,  Infectious diseases etc.

 

Actively involved & has been part of Phase I to III trials and Patient based Pk Studies in different roles starting from CRC to VP Clinical Operations.

Thanuja Naidu

VICE PRESIDENT – BUSINESS OPS

 Over 30 years of industry experience, including leadership of APAC clinical operations. Core expertise includes end-to-end clinical operations for the conduct of Phase I–IV clinical trials, project management, and regulatory affairs, with proven country management experience within a multinational CRO environment. 

 

 

Instrumental in establishing and scaling a Global Data Delivery Centre in India, driving operational excellence. Brings broad therapeutic experience including infectious diseases, oncology, rare diseases, and vaccines,. Has experience in managing MD and IVD trials, complex, global clinical development programs.

Sandeep Adsule​

MANAGING DIRECTOR

Over 27 years of experience, across all phases of Clinical Trials and multiple therapeutic areas.

 

Successfully managed Asia-Pacific business, Singapore, Australia, New Zealand, South Korea, Taiwan, Thailand, Vietnam, China and Japan with Chiltern for more than 5 years.

 

Played vital role  in setting up the relationship with 3 partner CROs in APAC. Set-up the PV Business Unit in India and achieved team size of 30 FTEs in a span of 1.5 years.

Anuradha Kini

Vice President – Business Development

Anuradha Kini is a seasoned clinical research professional with over 25 years of experience in the CRO and pharmaceutical industry, leading complex clinical and operational programs from planning through execution. She comes with a strong track record of delivering high-impact initiatives across global, cross-functional teams and is recognized for her strategic mindset, business acumen, and ability to drive results.

Anu is an effective leader who fosters a collaborative, accountable culture and consistently delivers high-quality outcomes in complex clinical environments. She excels in building trusted partnerships with sponsors, clients, and internal stakeholders, ensuring alignment through transparent communication and a strong focus on client needs.

Her expertise spans program and project management, stakeholder engagement, risk management, and process optimization. By combining analytical rigor with clear communication, she drives operational efficiency and ensures timely, successful project delivery.

Santhosh Param

Vice President, Strategic Growth & AI (UK & EU)  

Santhosh Param leads Clinnex’s UK/EU growth, with an intent to establish Clinnex as a modern and trusted CRO Partner for Pharma and Biotech innovators in this region. 

With a 30+ years’ track-record in consulting, marketing, business development, and digital transformation, Santhosh has successfully navigated the complexities of regional and global initiatives across diverse cultural and regulatory landscapes in the United Kingdom, EU and Asia Pacific.

He leverages a decade-long Healthcare and Health-Tech strategy experience within highly regulated clinical settings including the NHS UK, to augment and integrate AI/ML and Agentic technologies into the CRO workstacks. He will also lend his expertise in AI Governance to ensure safe, secure, and responsible deployments.  

Santhosh holds an MBA from California State University, East Bay and an MSc in Software Systems from NTU, Singapore. 

Harsha Yavagal

CO-FOUNDER & HEAD APAC STRATEGIC PARTNERSHIPS

Based in Singapore , Harsha brings over 20+ years of experience in the pharmaceutical and clinical development industry, with a strong track record of delivering end-to-end business solutions across Asia Pacific markets.

He has worked across diverse therapeutic areas including Oncology, Cardiovascular, Neurology, Respiratory, Gastroenterology, Anti-infectives, Dermatology, and Medical Devices.

He has led innovation portfolio strategies and the successful commercialization of new products across APAC, India, the Middle East, and Africa. With extensive experience managing regulatory audits and inspections, including USFDA inspections for clinical studies, he brings deep expertise in compliance and clinical development.

In his new role, he will focus on driving growth by building strategic partnerships and strengthening capabilities across Asia Pacific through a regionally focused operating model.