Service

Clinical Supply Management

Efficient management of clinical supplies is crucial to the success of trial. Our dedicated team ensures streamlined logistics, inventory, and distribution of supplies, maintaining compliance and minimizing disruptions. We at Expecto, leverage advanced forecasting tools for precise planning, ensuring your investigational products reaches global sites seamlessly.

From initial planning to execution, we handle every aspect, safeguarding the integrity of your research and ensuring seamless supply chain management. Embrace the future of Clinical Supply Management with Expecto Health Science – where innovation, reliability, and patient safety converge to elevate your clinical trials to new heights.

Clinical Operation

Expecto Health Science is on a mission to redefine the landscape of healthcare through our unwavering commitment to innovation and excellence in Clinical Operations. As a beacon of progress in the field, we take pride in orchestrating clinical trials that drive medical breakthroughs and shape the future of patient care. Our Clinical Operations team, led by industry experts, meticulously navigates every phase of the trial lifecycle.

Clinical monitoring services provided by Expecto involve selecting and qualifying investigative sites, conducting initiation visits, performing routine monitoring along with remote and virtual monitoring. These services ensure protocol compliance, accurate data collection, and participant safety. Expecto also supports patient recruitment, implement risk-based monitoring, and oversee regulatory compliance, contributing to the overall success of clinical trials. Contact us today and experience the expectation of excellence in every trial journey.

Data Management

Expecto’s data management team adheres to the highest industry standards, implementing stringent measures to safeguard sensitive information. Our understanding of global regulatory standards combined with regional insights ensures that your data management strategy aligns seamlessly with international compliance, fostering a harmonized approach to global clinical research.

Expecto offers customized solutions for Electronic Data Capture (EDC) systems, development of Clinical Data Management Plan (CDMP), ensuring accurate data entry and validation, maintaining a secure database, and implementing quality control checks. It includes data monitoring, security measures, standardization, and reconciliation. Effective data management is crucial for producing reliable results and meeting regulatory expectations. Our dedicated teams work collaboratively to implement robust data management practices throughout the trial lifecycle.

Following is concise overview of our key offerings:

  • Electronic Data Capture (EDC)
  • Clinical Data Management Plan (CDMP)
  • Data Entry and Validation
  • Database Design, Data Cleaning and Monitoring
  • Quality Control Checks
  • Data Security and Standardization
  • Data Transfer and Reconciliation
  • Query Management and Audit Trail
  • Database Lock
  • Regulatory Compliance

eTMF Management

Step into the future of clinical trial management with Expecto Health Science, where Electronic Trial Master File (eTMF) is not just a digital repository but a gateway to streamlined efficiency, compliance, and accelerated breakthroughs. Our commitment to cutting-edge eTMF solutions is reshaping the landscape of clinical research, ensuring precision and excellence at every stage. Expecto’s eTMF is fortified with robust security measures, ensuring the confidentiality and integrity of your trial data. This includes classifying documents, version control, quality checks, user access control, and generating metrics for monitoring.

Our eTMF is always audit-ready, compliant with regulatory standards, and integrate with other systems. Expecto plays a key role in collaborating with sites, post-trial archiving documents, and providing training on eTMF processes. Our effective eTMF management is crucial in regulatory compliance, inspections, and maintaining a comprehensive record of your clinical trial documentation.

Medical Writing

Our Medical Writers work closely with cross-functional teams, including researchers, clinicians, and regulatory experts, in crafting the clear, concise, and compliant documents tailored to meet the rigorous standards of clinical research. From protocol writing and regulatory submissions to scientific publications and patient-centric materials, our team ensures precision, excellence, quality and regulatory compliance for every document, supporting the success of your research endeavours.

Quality Assurance, Compliance, and Independent Auditing

Expecto sets the gold standard in clinical trial excellence through unparalleled Quality Assurance and Independent Auditing services. With a commitment to elevating the integrity and compliance of your trials, Expecto boasts a seasoned team of globally renowned experts who have successfully hosted USFDA, EMA, PMDA, MFDS, TGA, ANVISA, MCC and WHO along with numerous Regulatory Authority Inspections.

Expecto is dedicated to meticulous scrutiny of every trial aspect and work hand-in-hand with clients to secure trial robustness. Our comprehensive auditing services encompass regulatory compliance and data integrity, ensuring that your trial not only meets but exceeds industry benchmarks. Proactively addressing risks, Expecto Health Science goes beyond the checklist, safeguarding your trial’s success. Choose Expecto for a partnership that transcends expectations, where every audit is a collaborative effort towards excellence in clinical research. Contact us today to embark on a journey of uncompromising quality and compliance in your clinical trials.

FSP/Strategic Resourcing Solutions

Our specialized Functional Service Provision (FSP) Solutions provide strategic resourcing to bolster your clinical research efforts. We offer tailored, flexible models that seamlessly integrate with your different teams ensuring that you have the expertise and support you need. Whether you require temporary assistance, specific expertise, or a comprehensive FSP partnership, our customized solutions are designed to enhance the efficiency and effectiveness of your research initiatives which allows flexibility in resource allocation, risk-sharing and seamless collaboration.

Regulatory Strategy and Consultation

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Navigating the complex landscape of the regulatory environment is fundamental for successful clinical research project. Our expert regulatory strategists develop comprehensive plans tailored to your project and overall product development lifecycle, ensuring compliance with ever-evolving regulations. We offer proactive guidance on submissions, approvals, and compliance strategies, empowering your research to progress smoothly through regulatory pathways.

  • Regulatory Strategy for Product Lifecycle
  • Support for Global submissions to USFDA, EMA, PMDA, MFDS, CFDA, TGA etc,
  • Support as Importer of Record’s (IOR)
  • Liaison with Regulatory Authorities

RWE Study Management

Elevate your healthcare research paradigm with Expecto Health Science’s groundbreaking Real-World Evidence (RWE) Study Management services. In the era of data-driven healthcare, we empower you to extract meaningful insights from real-world data with precision and innovation. Expecto’s RWE Study Management seamlessly integrates advanced analytics, offering a comprehensive solution to bridge the gap between clinical trials and real-world patient outcomes. Our experienced team collaborates closely with clients to design and execute studies tailored to their unique objectives. With a commitment to excellence, we navigate the complexities of RWE, ensuring that your studies provide actionable insights for product’s real-world performance, including safety and effectiveness, and to make informed strategic decisions for market access and reimbursement.

Expecto Health Science is your trusted partner for pioneering Real-World Evidence Study Management.

Pharmacovigilance

At Expecto Health Sciences, we are dedicated to ushering in a new era of pharmaceutical safety through our cutting-edge Pharmacovigilance solutions. Patients safety is our topmost priority. Our team of seasoned experts navigates the intricate global regulatory landscape with ease, ensuring compliance with the latest pharmacovigilance guidelines. Harness the power of advanced technologies for systematic collection, assessment, monitoring and prevention of adverse effects or any other drug related issues. The overall suite is designed for signal detection and analysis, identifying safety concerns before they escalate. We offer tailored pharmacovigilance services, providing solutions that precisely align with your unique requirements.

DCT Management

Our commitment to innovation and patient-centricity is propelling us into a new era where trials are more accessible, inclusive, and efficient, ensuring accelerated progress in healthcare breakthroughs. Expecto Health Science believes in removing barriers to participation. With Decentralized Clinical Trials, we bring trials directly to the participant’s doorstep, offering flexibility and convenience without compromising the rigor of research.

Our services include protocol design for remote data collection, integrating technology, ensuring regulatory compliance, selecting and training sites, managing patient recruitment, implementing remote monitoring, and addressing logistics and supply chain challenges. The focus is on leveraging technology, optimizing patient engagement, and maintaining high-quality data while adhering to ethical and regulatory standards.

Expecto Health Science

Striving for research excellence

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