Clinical Trial Project Management | Clinical Data Management
A robust and customized solution especially focusing on the needs of small and mid-sized pharma companies.
Our Clinical Research Associates (CRAs) act as the liaison between the sites and the study team. CRAs are assigned to specific sites for the duration of the study to provide consistent support for sites. All monitoring activities are conducted in accordance with data integrity during each site visit, consistently retrieving high quality, on-time data. Nucleon’s clinical monitoring team ensures the adherence with standard operating procedures (SOPs) and strives to promote positive personal relationships with a high level of trust and confidence with all our customers.
We provide expertise in setting up and delivering end to end solution for
Fixed Dose Combination (FDC) Clinical Studies
Regulatory efforts towards rationalization and need for clinical data for FDCs has posed a unique challenge to Indian pharmaceutical industry. Evaluation of Fixed Dose Combination (FDC) for therapeutic justification or Rationale for each ingredient of FDC were earlier considered as irrational in the assessment report of the Prof Kokate Committee.
Real World Evidence Studies
Real-world evidence is the clinical evidence regarding the usage of marketed product & potential benefits or risks of a medical product derived from analysis of Real-world data.
Observational and non-interventional study of approved drug by Investigator Initiated Clinical Trials (IICT)
Successfully conducted a number of Real-world evidence observational studies (prospective &/or retrospective)
These type of studies supplement existing clinical information on usage of study product in broad routine clinical practice which can be helpful to support efficacy, safety claims on study product.
Regulatory Submission
- Pre-submission discussions with Drug Controller General of India’s (DCGI) office
- Preparing eDossiers for registration of Medical devices and drugs
- Application for permission to conduct clinical trials for New/Investigational Drug
- Prepare strategy and execute SEC meeting
- Resolve DCGI queries & Regulatory clearances from DCGI
- Application for permission to import of New Drug for sale in India
Inspection preparedness
Expertise in preparing your site and investigators for regulatory inspection.
Experience in conducting several USFDA, EMEA and DCGI inspections and no critical findings.
Clinical Data Management
Work on Paper/ EDC as per Customers requirements
In-house CDM collaborations on CT projects
Integration with MedDRA & WHO-DD coding dictionaries
Double layered data validation process – Manual & Programmatic review
Well equipped with CDISC 21 CFR Part 11 compliant CDM Software
Patient support programs
Accelerating Recruitment & Retention Strategy in Clinical Trials through Patient Support Programs (PSPs) 24×7 inbound Medical Information Call center (MICC). PSPs are an ideal way for you to directly support patients, improve adherence and optimize efficacy and outcomes for Clinical Trials.
Empowering Effective Patient Recruitment & Retention Strategy in Clinical Trials through PSP
Five key needs that our comprehensive patient support programs address.
Clinical: Providing patients with a point of contact during trials and assisting with transitioning from clinical to commercial drugs, specifically clinical trial support and risk evaluation and mitigation strategies.
Engagement: Specific engagement related solutions include enrollment and consent, case management, patient adherence programs, portals, assistance with appointments and scheduling, mobile health monitoring, telehealth, and advocacy.
Therapy: Connecting with patients to provide access to and support with their care. Specific therapy-related solutions include access to care, specialty pharmacy triage, distribution solutions, site of care/infusion site match, lab/test results coordination, and nurse visits.
Financial: Specific financial solutions include insurance verification, benefits investigation, claims appeals and re-coding, prior authorization, co-pay assistance, and bridge therapy programs.
Education: Solutions include medical information and pharmacovigilance, nursing educational support, and between-visit care.
Following are highlights of our Patient Support Program
- 24x7 Inbound support line for advice
- Access to registered nurses, clinicians and pharmacists
- Site training material for patients, customized to geographical and regulatory compliances
- Exhaustive monitoring with focus on protocol requirements to better identify
- Risk, non-compliance and poor performance and timely reporting of adverse events
- Planning for patient-visit schedules according to study parameters
- Reminder support alerts for missed appointments and medication
- Analysis of data trends including enrollment/dropout status and adverse events
- Fitness, diet counseling, smoking cessation and alcohol reduction programs
- Caregiver support as per criticality/complexity of disease in the trial