Our Service

Our Service

Tech-Enabled Site Solutions

Where Data Meets Execution

We turn site selection and patient recruitment from a flutter into a precise science. Our proprietary AI platform analyzes historical performance, real-time patient databases, and site-specific metrics to predict and guarantee enrollment success. We don't just find sites; we identify the right sites with data-driven certainty, slashing weeks off your planning timeline and de-risking your most critical pathway to patients.

End to end clinical trial services

Seamless Execution from Protocol to CSR

From the first draft of your protocol to the final clinical study report, Trialcraft provides a single point of accountability. Our integrated team manages every detail—project leadership, data management, biostatistics, and medical writing—ensuring flawless execution, strict adherence to timelines, and unwavering quality. We streamline communication and oversight, giving you clarity and control from start to finish.

Medical Writing service

These services are essential in the clinical research and pharmaceutical industries, ensuring that all documentation meets regulatory standards and is suitable for various audiences, including regulatory authorities, healthcare professionals, and patients. Here’s a brief overview of the key components of medical writing services: These includes preparation of

  • Clinical Study Protocols
  • Clinical Study Reports (CSRs)
  • Informed Consent Forms (ICFs)
  • Regulatory Submission Documents
  • Manuscripts for Publication
  • Abstracts and Posters
  • Standard Operating Procedures (SOPs)
  • Clinical Study report (CSR)
Regulatory Submission and Approval

Management of all regulatory submissions and communications with health authorities. This includes preparing and submitting Investigational New Drug (IND) applications, Clinical Trial Applications (CTAs), and ensuring compliance with local and international regulations.

Project Management services

Comprehensive oversight of the clinical trial process, including planning, execution, monitoring, and reporting. Project managers ensure that timelines, budgets, and quality standards are met.

Clinical Monitoring

Regular oversight of clinical trial sites to ensure compliance with study protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines. Monitors assess data integrity and participant safety

Data Management service

Collection, validation, and analysis of clinical trial data. This includes designing case report forms (CRFs), managing databases, preparation of Dossier files, maintaining TMF and ensuring data integrity and security

Statistical Analysis

Statistical Analysis services such as Study Design, Sample Size Calculation, Data Collection, Descriptive Statistics, Inferential Statistics, Multivariate Analysis, Data Interpretation, Reporting Results will be handled at Trialcraft

Quality Assurance (QA) Services

QA services help maintain the integrity of the data collected, protect the rights and welfare of study participants, and ensure that the research findings are credible and reliable. Our QA services include

  • Quality Management System (QMS)
  • Standard Operating Procedures (SOPs)
  • Training and Education on regulatory procedures
  • Site Audits and Inspections
  • Data management Quality Assurance
  • Risk Management
  • Monitoring and Reporting of clinical trial studies
  • Audits to ensure Regulatory Compliance
Archival Services

This includes systematic management and storage of study-related documents and data after the completion of a clinical trial. These services ensure that all essential records are preserved in secured storage area with strict access controls that only authorized personnel can retrieve or view archived documents and archiving documents and data in compliance with regulatory requirements and can be easily retrieved for future reference, audits, or inspections.

Investigational Product (IP) Storage and Retention Services

These services ensure that IPs are stored securely and maintained in compliance with regulatory requirements, thereby safeguarding the integrity of the trial and the safety of participants. It includes Secure Storage Facilities, Inventory Management, Compliance with Regulatory Requirements, Access Control, Labeling and Documentation, Dispensing and Accountability, Return and Destruction. We ensure that investigational products are stored securely, handled properly, and retained in compliance with regulatory standards, ultimately supporting the integrity and safety of the research process

Site Management Services

Your Ready-to-Activate Site Network

This is our foundation and your accelerator. We own and manage an exclusive network of pre-vetted, audit-ready hospital sites across India. This eliminates the traditional, lengthy site qualification process. Our deep, direct relationships with sites and our embedded training programs allow us to guarantee site activation in under 45 days, getting your trial from protocol to patient recruitment faster than any traditional CRO.

Site Selection

Identifying and evaluating potential clinical trial sites based on their capabilities, experience, patient population, and infrastructure. This includes conducting feasibility assessments to determine the site's suitability for the study.

Site Initiation

Conducting initiation visits to prepare sites for the study. This involves training site staff on the protocol, procedures, and regulatory requirements, as well as ensuring that all necessary documentation is in place.

Regulatory Compliance

Assisting sites in obtaining necessary regulatory approvals and ensuring compliance with local and international regulations, including ethics committee approvals.

Site Monitoring

Regularly monitoring site activities to ensure adherence to the study protocol, GCP, and regulatory requirements. This includes routine monitoring visits to assess data integrity, participant safety, and overall site performance.

Training and Support

Providing ongoing training and support to site staff, including Principal Investigators (PIs), Clinical Research Coordinators (CRCs), and other personnel, to ensure they are knowledgeable about the study and their responsibilities.

Patient Recruitment and Retention

Implementing strategies to enhance patient recruitment and retention at the site. This may involve outreach efforts, community engagement, and patient education initiatives.

Data Management

Ensuring accurate and timely data collection and reporting from the site. This includes overseeing the completion of case report forms (CRFs) and ensuring data quality.

Issue Resolution

Identifying and addressing any issues or challenges that arise during the trial, including protocol deviations, adverse events, and site performance concerns.

Site Close-Out

Conducting close-out visits at the end of the study to ensure that all study activities are completed, documentation is finalized, and investigational products are accounted for.

Archival Support

Assisting sites with the proper archival of study documents and data in compliance with regulatory requirements for record retention.

Monitoring & Consulting Services

Strategic Insight for Optimal Outcomes

Go beyond standard monitoring with our strategic partnership. We provide expert, risk-based monitoring that focuses on critical data and processes, ensuring quality and compliance while optimizing resources. Furthermore, our seasoned consultants offer strategic guidance on regulatory pathways, operational challenges, and therapeutic area strategy, helping you navigate complexities and maximize the success of your clinical development program.