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Site Solutions

Optimize your existing clinical research site's performance with Wellnet Research Solutions' comprehensive remote support. Our team provides expert guidance and solutions from a distance, visiting the site only when absolutely necessary to ensure optimal efficiency and effectiveness. Our expert services are specifically designed for already ongoing sites, helping you to:

  • Enhance operational efficiency
  • Improve financial management
  • Strengthen regulatory compliance
  • Boost study coordination and management
  • Ensure high-quality data and results

Our services include, but are not limited to:

Quality Assurance/Quality Control

To ensure compliance to Good Clinical Practice (GCP)
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Regulatory Affairs

To ensure compliance to laws, regulations and guidelines
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Financial Management

To implement and manage a CTMS
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CTA/Budget Negotiations

To ensure successful Project Outcomes
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Business Development

To expand trial and recruitment opportunities for your site's success
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Remote Back-up Study Coordination

To collaborate and provide backup to onsite activities
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Staffing

To build a high performing research team that advances institutional objectives
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IT Solutions

To ensure reliable connectivity, data management and team collaboration
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Office Management

To optimize processes and productivity
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Quality Assurance/Quality Control

To ensure compliance to Good Clinical Practice (GCP)

We employ a meticulous approach to quality assurance and quality control, leveraging risk-based auditing techniques to identify and mitigate potential risks throughout the research process. Through the implementation of robust quality indicators, we continuously track and assess the performance of our operation, doing so we ensure you are aligned to regulatory requirements and attractive to the industry as a site to work with. Our quality team also provides onsite visits as preparation to FDA inspections or Sponsor/CRO audits.

Regulatory Affairs

To ensure compliance to laws, regulations and guidelines

We have a remote team that works closely with onsite CRCs, possessing extensive experience with all central IRBs. This enables us to effectively manage all aspects of the research process, including initial submissions, continuous reviews, study close-outs, modifications and amendments, internal audits, adverse event reporting, and more.

This division is dedicated to providing comprehensive regulatory guidance and support to ensure adherence to all relevant regulations and guidelines in the field of clinical research.

One of our key responsibilities is to offer regulatory guidance and compliance support to all stakeholders involved in our research endeavors. We stay abreast of the latest regulatory requirements and provide expert advice to ensure that all aspects of our projects meet regulatory standards. In addition to other regulatory support tasks, our staff manages all correspondence with IRBs, guaranteeing the prompt and accurate submission of protocol materials and streamlining the review procedure.

Financial Management

To implement and manage a CTMS

Our company’s Financial Administration department, which meticulously oversees all aspects of billing, payments, collections, and financial management, is the cornerstone of our operational efficiency. We safeguard the organization’s financial health through an advanced Clinical Trial Management System (CTMS), which streamlines and integrates the management of clinical trials, ensuring accurate budgeting, efficient resource allocation, and comprehensive tracking of financial activities. This system not only enhances our operational capabilities but also upholds the highest standards of ethics and transparency by maintaining a keen focus on detail and a commitment to excellence in all our processes.

The extensive experience of our negotiation team in cost management enables us to secure successful negotiations by leveraging market knowledge to reduce the risk of overpricing. Our team’s expertise ensures that we achieve favorable terms while preserving financial integrity and efficiency.

CTA/Budget Negotiations

To ensure successful Project Outcomes

As the Contracting division at Wellnet Research Solutions, we are dedicated to the meticulous negotiation and management of sponsor contracts, ensuring that all parties involved are aligned and well-supported throughout the clinical research process.

Our team specializes in the art of contract negotiation, leveraging our expertise and industry knowledge to secure favorable terms and conditions for our clients. From crafting initial contract proposals to navigating complex legal frameworks, we meticulously analyze each agreement to protect the interests of both our company and sponsors.

Business Development

To expand trial and recruitment opportunities for your site's success

As the Business Development team at our company, we specialize in fostering partnerships and driving growth within the clinical research landscape. With a diverse portfolio spanning multiple medical specialties including rheumatology, nephrology, dermatology, internal medicine, oncology, cardiology, pulmonology, and beyond, we are dedicated to connecting sponsors, pharmaceutical giants, and Contract Research Organizations (CROs) with cutting-edge clinical studies.

Remote Back-up Study Coordination

To collaborate and provide backup to onsite activities

Recognizing that one of the main challenges sites faces can be the absence of the primary CRC or their workload overload, we have developed the Remote Backup Clinical Research Coordinator service. This backup CRC is designated to handle tasks such as scheduling patient visits, identifying new patients, conducting protocol-specific follow-up calls, and other activities appropriate for a remote position.

Our remote study coordinator team comprises experienced professionals dedicated to overseeing various tasks essential for the successful execution of clinical trials. Primary responsibilities include:

  • Manages all aspects of study coordination, ensuring smooth operations from start to finish.
  • Possess in-depth knowledge of study protocols, ensuring adherence to study procedures and guidelines.
  • Collect and analyze data generated during the clinical trial, maintaining accuracy and integrity throughout the process.
  • Actively recruit and pre-screen potential trial participants, ensuring eligibility criteria are met and maintaining participant enrollment targets.
  • They ensure compliance with regulatory requirements, study protocols, and Good Clinical Practice (GCP) guidelines throughout the trial.

Staffing

To build a high performing research team that advances institutional objectives

At Wellnet Research Solutions, we manage every aspect of the employee lifecycle, from recruitment and selection to onboarding and beyond. Our team seeks out and selects top talent for roles, including experienced CRCs and individuals from medical backgrounds for regulatory affairs.

Using a variety of platforms and recruitment tactics, our team actively seeks for and selects the best applicants to join our business. To make sure that candidates not only fit the job requirements but also complement our business culture and values, we put candidates through extensive interviews and assessments. After a candidate is chosen, we negotiate employment conditions, make job offers, and take care of all the legal paperwork needed for onboarding. We make sure that labor laws, immigration rules, and other legal obligations are followed, giving new hires a smooth and compliant onboarding process.

IT Solutions

To ensure reliable connectivity, data management and team collaboration

This service ensures that all IT infrastructure, including hardware, software, and network systems, functions efficiently and securely. In this department we offer system integration, technology support, data security, software management, infrastructure management, user training, and innovation and upgrades.

Office Management

To optimize processes and productivity

Designed to ensure the efficient and smooth operation of your research site. We provide comprehensive support across various administrative functions, allowing you to focus on your core research activities. Our office management services cover essential areas including:

  • Purchasing: Procuring a diverse range of items including medical equipment, medical supplies, technological equipment, personnel supplies and general needs of the site.
  • Worktime control: Implementation of systems for recording work hours, breaks, and overtime.
  • Patient reimbursement control: Ensures a seamless and efficient process for patient reimbursements through card payments. Having as benefits payments processed quickly, patients receive funds directly, clear records, easier tracking, and a risk reduction of errors and fraud.