Our Expertise in Routine CDM

DATABASE BUILD/S & MAINTENANCE

ClinTrack excel at database construction/build, leveraging our deep understandings & experience of entity relationships of elements and table structures within a database model and then builds with EDC softwares like Medidata Rave® and Medrio sort of platforms. Apart from that we can build on multiple other platforms as we have experties for most of the EDCs available in market. This enables us to deliver highly efficient and tailored solutions for clinical trials across all phases and therapeutic areas. Our services encompass full-cycle database support, from initial setup to closeout, or can be tailored to specific needs such as standalone build or programming services.

With our expertise across a variety of clinical data management (CDM) platforms, we can help you find the best fit for your study. We have clinical database programming experience with leading EDC platforms. We are proficient in below (no limited to) CDM platforms, including:

--> Medidata Rave®

--> Oracle InForm

--> DATATRAK ONE

--> Medrio

--> Clinical Studio

--> Bioclinica Express

--> iDataFax®

--> IBM Clinical Development

--> ClinCapture

--> VEEVA Vault

--> OpenClinica

USER ACCESS MANAGEMENT AND CONTROL

Robust user access control is paramount for the security of your clinical trial data. Clintrack provides comprehensive user management services, including:

• Granular Access Control: We implement role-based access controls, ensuring each user has access only to the data and functionalities necessary for their specific role (e.g., data entry, medical coding, data review).
• Seamless User Onboarding/Offboarding: We facilitate smooth user onboarding and offboarding processes for all CDMS and related IT resources.
• Enhanced Data Security: Our approach minimizes the risk of unauthorized data access, safeguarding the integrity and confidentiality of your clinical trial data.

DATA REVIEW

Clintrack empowers your team with robust data review capabilities to:

• Identify and resolve data issues: Pinpoint potential inconsistencies, discrepancies between data sources, and deviations from the study protocol.
• Gain actionable insights: Generate pre-defined reports and outputs that provide timely and meaningful insights into safety, efficacy, and overall study progress.
• Enhance data quality: Proactively address data quality concerns, ensuring the integrity and reliability of your clinical trial data.

MEDICAL CODING

Multicenter clinical trials generate vast amounts of data across various sources, including paper and electronic case report forms (CRFs). This data, encompassing adverse events, medical history, and concomitant medications, often exhibits inconsistencies in recording, particularly across international sites.

• To ensure data integrity and facilitate regulatory submissions, standardized medical coding is crucial. The FDA and other regulatory authorities require the use of industry-standard dictionaries such as MedDRA (for adverse events and medical history) and WHO Drug (for concomitant medications). At Clintrack, we possess years of expertise in managing critical medical coding processes. Our team ensures consistent and accurate coding, facilitating seamless regulatory submissions and supporting data analysis.

SOP DEVELOPMENT

Leveraging years of industry experience, we specialize in developing and reviewing comprehensive Standard Operating Procedures (SOPs) for both in-house and outsourced data management.

Our well-defined SOPs:

• Enhance efficiency and quality: Streamline processes, ensure consistent data handling, and optimize overall data management performance.
• Facilitate communication and collaboration: Foster clear communication and seamless collaboration among team members.
• Ensure regulatory compliance: Guarantee adherence to industry best practices and regulatory guidelines.

STUDY RESCUE (LOW PERFORMANCE or LIMITED BUDGETS)

Struggling with a stalled clinical trial? Facing data quality issues or vendor challenges? Clintrack provides expert rescue services for trials that have gone off track.

• Deep Expertise: With decades of combined experience, we possess the knowledge and skills to navigate complex challenges and optimize data management functions across all trial phases.
• Rapid Response: Our team of highly skilled data managers and IT resources swiftly deploy flexible solutions to address your immediate needs.
• Tailored Approach: We can seamlessly integrate with your existing SOPs, develop new ones, or create a hybrid approach that perfectly aligns with your study requirements.
• Risk Mitigation: We proactively mitigate further risks and get your trial back on track, ensuring data quality and successful study outcomes. 

VENDOR QUALIFICATIONS & AUDITS

Ensuring regulatory compliance requires rigorous vendor audits. Whether you're selecting, qualifying, or re-qualifying IT vendors, from data centers to software providers, Clintrack possesses the expertise to guide you. We can conduct or participate in vendor audits, helping your organization make informed decisions about service providers, products, and quality practices.

ALL OTHER A-2-Z TASK/s NEEDING DM INTERVENTIONS 

 Clintrack provides expert services for trials needing -

• IND/NDA Submissions: With decades of combined experience, we possess the knowledge and skills to navigate complex challenges and optimize data outcomes from preclinical to clinical phases and organize it in such a manner for a successfull IND(Istitutional New Drug) or, NDA (New Drug Application) submission/s to FDA and simmilar regulatory bodies worldwide.
• FDA Audits: Our team of highly skilled data managers and IT resources are fully capable of helping you in any urgency of an FDA audit.
• RBQM: We can seamlessly work with Clinical teams on RBM approach and have robust RBQM standards.
• Other DM tasks: Apart from all above, there are several specializations we have within CDM space which can be used on demand.