InventaLife

Menu
Menu

Clinical Trials

Reliable Execution from Phase I to Phase IV
InventaLife offers integrated clinical trial services to support the full spectrum of drug and product development.

Our Offerings

Phase I–IV Trials

At InventaLife Research Solutions, we offer comprehensive clinical trial services across Phase I to Phase IV, ensuring seamless progression from early human testing to post-marketing surveillance. Our scientifically driven, regulatory-compliant approach is designed to accelerate product development while maintaining the highest standards of safety and data integrity.

Our end-to-end clinical trial capabilities ensure every phase is conducted efficiently, ethically, and with scientific excellence—bringing your products to market faster and safer.

Phase I trials

Focus on assessing safety, tolerability, pharmacokinetics, and pharmacodynamics in a small group of healthy volunteers or patients. Our expert teams ensure risk management and ethical oversight throughout.

Phase II trials

Evaluate efficacy and optimal dosing in target patient populations. We design and conduct well-controlled studies that generate critical efficacy data to support further development.

Phase III trials

Involve large-scale, multicenter studies to confirm therapeutic effectiveness and monitor adverse reactions. We manage the complexity of these trials with robust project planning, global site coordination, and precise data management.

Phase IV trials

Post-marketing studies, provide real-world insights into long-term safety, effectiveness, and usage patterns. We support sponsors in fulfilling regulatory commitments and exploring new indications.

Protocol Development

InventaLife develops scientifically sound, regulatory-compliant clinical trial protocols tailored to your study’s goals. Our expert team ensures clear design, safety focus, and operational feasibility across all trial phases, with thorough stakeholder input and regulatory alignment, helping lay a solid foundation for trial success.

Regulatory Affairs

InventaLife offers end-to-end regulatory support, ensuring compliance from trial initiation to market approval. Our experts guide submissions, ethics approvals, and ongoing compliance across global authorities like DCGI, USFDA, and EMA. We provide strategic insight and execution for all product types, including complex and herbal formulations.

Site Management

InventaLife ensures efficient site management through strategic site selection, investigator training, and ongoing monitoring. We support sites in protocol adherence, GCP compliance, and timely data delivery. Our proactive approach and strong local relationships drive smooth operations, high-quality data, and on-time trial execution.

Site Audit and Monitoring

InventaLife provides thorough site audit and monitoring services using risk-based strategies and ICH-GCP standards. We ensure protocol compliance, data accuracy, and patient safety through regular visits, CAPA planning, and inspection readiness. Our expert team safeguards trial quality and regulatory alignment throughout the study lifecycle.

Data Management

Secure and accurate data handling with validated systems.
InventaLife delivers secure, end-to-end data management using validated EDC systems. We ensure accurate, compliant, and audit-ready trial data through expert CRF design, query resolution, and continuous quality checks. Our proactive approach supports timely data cleaning, reconciliation, and database locks for reliable analysis and regulatory submissions.

Pharmacovigilance

InventaLife offers end-to-end pharmacovigilance services to ensure patient safety and regulatory compliance. From case processing to risk management plans and aggregate safety reports, our expert team manages clinical and post-marketing safety monitoring with precision, using global PV standards and advanced systems for real-time safety data capture and reporting.

Biostatistics Services

InventaLife offers comprehensive biostatistics services from study design to final analysis. We provide sample size calculation, SAP development, interim analysis, and regulatory-ready reports using validated tools like SAS and R. Our expert team ensures statistically sound, compliant, and actionable results that support informed clinical decisions.

Medical Writing and Publication

InventaLife provides expert medical writing and publication services, delivering regulatory-compliant, scientifically accurate documents for all clinical stages. From protocols to manuscripts, our team ensures clarity, precision, and global acceptance. We offer full publication support, including journal selection and submission management, to help communicate your research effectively and successfully.

Therapeutic Areas

InventaLife supports diverse therapeutic areas including neurology, oncology, endocrinology, infectious diseases, and more. Our expert team designs tailored, regulatory-compliant studies to meet each domain’s unique challenges. With deep scientific insight and cross-functional expertise, we ensure efficient, high-quality clinical research across a broad spectrum of complex medical conditions.

At InventaLife, we understand that a well-designed clinical trial protocol is the cornerstone of a successful study. Our protocol development services are designed to ensure that each clinical protocol is scientifically robust, ethically sound, and fully compliant with global regulatory standards.

Our experienced medical and regulatory writing teams work closely with clients to develop customized protocols that align with study objectives, therapeutic area requirements, and target regulatory authorities (such as DCGI, ICH-GCP, USFDA, EMA, etc.). We balance scientific accuracy with operational feasibility to design protocols that are clear, practical, and executable across varied clinical settings.

We pay meticulous attention to critical elements such as study design, eligibility criteria, endpoints, randomization methods, treatment plans, safety assessments, and statistical methodologies. Whether for early-phase trials or complex multicenter Phase III studies, our protocols are designed to minimize risks, optimize timelines, and ensure patient safety.

Our comprehensive process includes stakeholder consultation, literature review, regulatory cross-checks, and integration of feedback to deliver protocols that stand up to regulatory scrutiny and operational execution.

By choosing InventaLife, you gain a partner that brings clarity, compliance, and clinical insight to every protocol we design, laying a strong foundation for your trial’s success.

At InventaLife, our Regulatory Affairs team offers comprehensive, end-to-end support to navigate the complex and evolving landscape of local and international regulatory requirements. We ensure that your product development journeyfrom clinical trial initiation to market authorizationis compliant, efficient, and strategically aligned.

Our experts are well-versed with regulatory guidelines issued by authorities such as DCGI, USFDA, EMA, MHRA, and ICH-GCP, enabling us to offer region-specific and global regulatory solutions. Whether you are initiating an Investigational New Drug (IND) application, seeking Clinical Trial Approvals (CTAs), or planning for New Drug Applications (NDAs), we provide guidance and execution at every step.

Our services include:
* Regulatory strategy and planning
* Preparation and submission of regulatory dossiers
* Managing the ethics committee and institutional approvals
* Liaison with regulatory bodies and investigators
* Ongoing compliance monitoring and updates

We also assist with gap analysis, regulatory intelligence, and product classification for complex studies, including herbal, nutraceutical, and combination products.

With InventaLife as your regulatory partner, you gain more than just documentation support; you gain a strategic ally committed to accelerating your development timelines while ensuring full compliance with national and international standards.

At InventaLife, we recognize that effective site management is crucial to the success of any clinical trial. Our comprehensive site management services are designed to ensure that every study site performs efficiently, complies with regulatory standards, and delivers high-quality data within timelines.

We begin with strategic site selection, identifying investigators and institutions with the appropriate patient population, infrastructure, and prior experience in clinical research. Our thorough feasibility assessments help minimize risks and maximize enrollment potential.

Once sites are selected, we provide intensive training and initiation support to ensure complete understanding of study protocols, Good Clinical Practice (GCP) guidelines, and data reporting systems. This fosters consistency, accuracy, and accountability from the very first patient visit.

Throughout the study, our team provides ongoing monitoring and site support, ensuring adherence to protocols, timely data entry, and proper documentation. We also conduct site audits and performance reviews to proactively address any operational or compliance issues.

By leveraging strong relationships with investigators and a deep understanding of local site dynamics, InventaLife ensures smooth site operations, rapid startup, and reliable data, ensuring your trial stays on track and maintains the highest scientific and ethical standards.

At InventaLife, we offer robust Site Audit and Monitoring services designed to ensure that your clinical trials are conducted with the highest levels of quality, compliance and integrity. Our approach is grounded in risk-based monitoring (RBM) strategies and strict adherence to ICH-GCP guidelines, ensuring both efficiency and regulatory readiness.

Our monitoring team conducts routine, for-cause, and close-out visits, assessing site performance, protocol compliance, data accuracy, and patient safety. We focus on identifying risks early and resolving issues proactively to prevent protocol deviations and data inconsistencies.

Our audits include:

  • Verification of source data and CRFs
  • Review of informed consent processes
  • Documentation compliance checks
  • Investigational product accountability
  • Site staff training evaluations
  • Corrective and preventive action (CAPA) plans

With a strong emphasis on quality assurance, our auditors also prepare sites for regulatory inspections by national and international authorities (e.g., DCGI, USFDA, EMA).

Through continuous engagement, transparent communication, and real-time issue tracking, InventaLife ensures that all trial sites maintain compliance and data reliability throughout the study lifecycle.

With our auditing and monitoring expertise, you can trust that your trial is in safe, experienced, and compliant hands.

Secure and accurate data handling with validated systems.

 At InventaLife, we offer end-to-end clinical data management services that ensure the integrity, accuracy, and confidentiality of your trial data. Our processes are built on industry best practices and comply with GCP, 21 CFR Part 11, and other global regulatory standards.

We use validated Electronic Data Capture (EDC) systems to streamline data collection, enable real-time monitoring, and minimize entry errors. Our experienced data management team is skilled in designing case report forms (CRFs), developing data validation plans, and executing edit checks to ensure high-quality, analyzable datasets.

Our services include:

  • CRF/eCRF design and testing
  • Database setup, validation, and maintenance
  • Query management and discrepancy resolution
  • Data cleaning and reconciliation (e.g., with safety and lab data)
  • Interim and final database lock
  • Data export for statistical analysis and regulatory submission

We understand that clean, timely, and audit-ready data is the foundation of credible clinical research. Our proactive data review process, combined with continuous quality control, ensures early issue identification and fast resolution.

With InventaLife, sponsors receive reliable, secure, and regulatory-compliant data management supportessential for driving informed decisions and successful outcomes.

At InventaLife, we provide comprehensive pharmacovigilance (PV) services to ensure continuous safety monitoring and effective risk management throughout the lifecycle of your product. Patient safety is at the heart of every clinical development program, and our PV solutions are designed to meet both regulatory and ethical obligations with precision and diligence.

Our expert team supports sponsors with both clinical trial safety monitoring and post-marketing surveillance. We adhere strictly to global pharmacovigilance guidelines, including ICH, GVP, DCGI, and FDA regulations, offering timely detection, assessment, reporting, and prevention of adverse events.

 Our key services include:

  • Case processing and Individual Case Safety Reports (ICSRs)
  • Medical review and narrative writing
  • Signal detection and risk-benefit analysis
  • Development of Risk Management Plans (RMPs)
  • Aggregate safety reports (DSURs, PSURs, PBRERs)
  • Regulatory reporting and compliance management
  • PV system setup and audits

With advanced safety databases and a proactive approach, we ensure high-quality, real-time safety data capture and interpretation. Whether in pre-approval clinical trials or post-marketing phases, InventaLife offers a robust pharmacovigilance framework that safeguards both the patient and your product.

At InventaLife, our biostatistics services form the backbone of scientifically sound and data-driven clinical research. We provide end-to-end statistical support that guides the design, execution, and interpretation of clinical trials, ensuring that your data is transformed into credible and actionable evidence.

Our biostatisticians are involved from the earliest stages of study design, providing statistical planning that aligns with clinical objectives and regulatory expectations. This includes defining appropriate endpoints, determining sample size, and establishing randomization methods to ensure statistical validity and power.

 Our key services include:

  • Study design consultation and statistical protocol development
  • Sample size calculation and power analysis
  • Randomization schedule generation
  • Interim analysis for early decision-making
  • Statistical analysis plans (SAPs)
  • Descriptive and inferential statistics
  • Final statistical reports for regulatory submission
  • Support for Data Safety Monitoring Boards (DSMBs)

We utilize validated statistical software such as SAS, R, and SPSS, ensuring high-quality data outputs that meet international standards. Whether for early-phase trials or large-scale multicenter studies, InventaLife delivers statistical solutions that are precise, transparent, and regulatory-compliant.

With our biostatistics expertise, you gain confidence in your data, and the decisions that rely on it.

At InventaLife, our Medical Writing and Publication services are tailored to deliver scientifically accurate, regulatory-compliant, and publication-ready documents that support every stage of your clinical development program. Our experienced medical writers combine scientific knowledge with regulatory expertise to produce clear, concise, and impactful content.

We support the creation of a wide range of regulatory documents required for clinical trial applications, product approvals, and post-marketing submissions. Each document is developed in alignment with ICH, GCP, and country-specific guidelines to ensure global acceptability.

 Our services include:

  • Clinical study protocols and investigator brochures
  • Clinical Study Reports (CSRs)
  • Informed Consent Forms (ICFs)
  • Safety narratives and pharmacovigilance documents
  • Common Technical Documents (CTDs) for regulatory filings
  • Manuscript development for peer-reviewed journals
  • Conference abstracts, posters, and slide decks
  • Literature reviews and scientific summaries

We ensure that all medical content is scientifically sound, publication-ready, and aligned with your study objectives and regulatory needs. In addition to technical accuracy, we offer specialized manuscript writing services tailored for high-impact journals, including adherence to journal-specific formatting, reference styles, and editorial guidelines. Our team also provides end-to-end publication support, from journal selection and cover letter drafting to managing reviewer comments and resubmissions, until final acceptance. With robust quality control processes and strict adherence to timelines, InventaLife helps you communicate your research effectively and maximize your chances of successful publication.

At InventaLife, we bring extensive experience across a wide range of therapeutic areas, enabling us to support diverse clinical development programs with precision and expertise. Our cross-functional team of medical experts, clinical researchers, and biostatisticians ensures that each study is tailored to the specific challenges and nuances of the therapeutic domain.

Our team is equipped to design and manage studies tailored to the unique scientific, regulatory, and logistical challenges within each therapeutic area. We have initiated and are actively supporting studies in the following key domains:

Neurology: Our team supports studies in neurodegenerative diseases. We are well-versed in the complexities of CNS trials, including cognitive assessments, long-term outcome tracking, and patient adherence strategies.

Oncology: With capabilities spanning both solid tumors and hematologic malignancies, we offer support for early-phase trials, complex adaptive designs, and biomarker-driven protocols. Our oncology operations are built to manage the high complexity and dynamic nature of cancer research.

 

Endocrinology: In metabolic and hormonal disorders such as diabetes, thyroid dysfunction, and metabolic syndrome, we emphasize patient-centric trial designs, efficient recruitment, and stringent regulatory compliance.

Infectious Diseases: From managing pandemic-response trials to chronic infectious conditions like HIV, we deliver rapid, responsive clinical trial services that uphold the highest standards for safety, data integrity, and efficacy evaluation.

 Other Therapeutic Areas: Our expanding portfolio also includes expertise in cardiology, nephrology, gastroenterology, pulmonology, rheumatology, and dermatology, allowing us to support a wide range of complex, multi-system disorders with customized clinical solutions.

As a growing CRO, InventaLife combines adaptability with deep therapeutic knowledge to ensure your clinical development programs are executed with scientific integrity and operational excellence. We are your trusted partner in transforming clinical insights into meaningful outcomes.

Scroll to Top