pharmaceutical consultancy

We Assure, because We Ensure

End to end services for BA/BE studies starting from Site Qualification Audit to Final report review

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About Us

Splorgen pharma LLC is a fast-growing pharmaceutical consultancy service provider. Splorgen has established itself as a frontrunner in providing monitoring services for Bioavailability/Bioequivalence (BA/BE) studies, since the inception in 2020. Splorgen brings along the vast collective experience of the team members whose primary field of expertise is BA/BE studies. The diverse experience and expertise of the team enables Splorgen to offer end to end services for BA/BE studies starting from Site Qualification Audit to Final report review.

A fast-growing pharmaceutical consultancy service provider

Our Mission

Become the world's premier, fully integrated one stop solution provider to the Pharmaceutical, Food, Healthcare and Personal Care Industries.

Our Vision

To recruit qualified and competent manpower in order to achieve the business goal, i.e. to have right people at right time with right mix of skills

Our Service

We offer end-to-end support for your trials; Before it starts and even after completion

Site Qualification Audit

One of the major challenges faced by pharmaceutical companies while outsourcing research is identifying the right player. Splorgen’s Site Qualification Audit program comes in handy here, in helping the client to select the right service provider.

  • Site Qualification Audits rooted in principles of Good Clinical Practices (GCP) and Good Laboratory Practices (GLP)
  • Extensive checklist addressing minute details
  • Focus from the legal identity to actual capabilities and compliance of the site
  • Experience and Qualification of Site staff
  • Regulatory and statutory approvals
  • Early identification of risks
  • Solution oriented audit discussions
  • Overall compliance to SOPs and Regulatory requirements
  • Quality Management Systems
  • Experience in successfully facing facility audits from various regulatory authorities in the past
  • Knowledge of what to expect from the regulators

BA/BE Study monitoring

BA/BE studies are under constant scrutiny from the regulators. Compliance is a challenge, especially when the site is dealing with multiple studies simultaneously. Splorgen functions as the eyes of the sponsor here; We watch it for you.
Our BA/BE study monitoring program offers end to end services, before beginning of the study (Site Initiation) till after completion (Report review).

    Site Initiation Visit

  • Ensures the site is ready to initiate the study
  • All regulatory approvals are in place
  • Validity of statutory approvals for site and third-party vendors
  • Protocol and informed consent documents completeness and approval status
  • All resources are adequate
  • Review of duty delegation and training
  • Identification and resolution of early issues before actual start of the study
  • Update of Trial Master File (TMF) with documents required before study
  • Availability of validated analytical method
  • Calibration status of equipment
  • Over all compliance before start of the study

Clinical Phase Monitoring

Clinical phase monitoring is offered in three phases- In-process Monitoring visits, close out visit, Retrospective review

In-process monitoring

  • Monitoring the study as it happens
  • Evaluation of volunteer screening and recruitment
  • Ensuring transparency in Informed Consent Process
  • Ensuring the right IMP is dispensed and dosed as per the randomization code
  • PK sampling, Sample processing and Storage monitoring
  • Online Review of case Report Forms (CRF)
  • Review of Periodic update of TMF
  • Review of updates in duty delegation and training
  • Ensuring overall compliance with protocol, GCP and other regulatory requirements
  • Provide project update to sponsor time to time
  • Safety (AEs, SAEs) update to sponsor
  • Monitoring report at the end of each period

Close out visit

  • Ensuring Corrective Action and Preventive Action (CAPA) for monitoring observations
  • Satisfactory resolution of all AEs/SAEs
  • Evaluation of post study medical screening
  • Accountability of IMPs
  • Review of TMF for completeness

Retrospective review

  • Complete review of CRFs and other source data
  • Review of Report and completeness of all documents/ Annexures of report

Bioanalytical Phase Monitoring

Bioanalytical is a very crucial phase in BA/BE studies where a minor error can lead to total misrepresentation of the study. Splorgen’s Bioanalytical Monitoring program ensures Accuracy and Precision of the conduct of Bioanalytical phase.

Method Development and Method Validation

  • Review of method development data and ensure the rationale behind the method is well established
  • Method validation is performed as per the regulatory requirements
  • All experiments are performed
  • Stability of the analyte is well established in solution and in matrix
  • Stability is established for different conditions anticipated during study
  • Selectivity and specificity of the method is adequately validated
  • Interference and matrix effects are addressed
  • Accuracy and precision of the method is ensured during validation
  • Review of Method Validation report

In-process bioanalytical monitoring

  • Online monitoring of sample processing and analysis
  • Ensuring that the method procedure is followed
  • Stock weighing and preparation of stock dilutions
  • Preparation of CCs and QCs in biological matrix
  • Sample tracking and storage conditions throughout the sample life cycle
  • Calibration status of equipment used
  • Expiry of solutions, Reagents, chemicals and stock dilutions used
  • Duty delegation and training of staff involved

Retrospective review

  • Review of source data
  • Review of result tables and chromatograms
  • Review of Audit Trail of analytical equipment
  • Review of sample processing details
  • Ensuring compliance to SOP for identification, analysis and reporting of repeat analysis
  • Incurred Sample Reanalysis review

Report Review

  • Extensive review of analytical report
  • Ensure that the report accurately reflects the raw data
  • All the required annexures are available and as per the source data

Get In Touch

we'd Love to hear from you

Contact Info

Splorgen Pharma LLC

Address

#B-215 2719, Hollywood Blvd. Florida 33020

Email

jk@splorgen.com

Phone

+1 9496649721

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