Services

1 . Clinical Trial Project Management

  • Sponsor relationships are essential to us and we strive to exceed your expectations
  • To ensure optimum communication a dedicated project manager is assigned to each sponsor account.
  • Managing the execution of your project by tracking all critical stages, offering prompt updates and personalized service to meet your individual requirements
  • Project Managers work closely with the Business Development team to foster strong working relationships with our clients and to maintain the highest levels of customer satisfaction

2 . Phase I, First-in-Man, Drug – Drug Interaction studies (DDI) & Bioavailability (BA)/Bioequivalence (BE)

BioSRL has the expertise to offer you the entire range of services for First-in-Man and Phase I clinical trials. A vigorous QC process to ensure data integrity

  • Services
  • Phase I studies (First-in-Man)
  • Drug-Drug interaction studies
  • Drug-Food interaction studies
  • Proof of concept studies
  • Safety and tolerability studies
  • Dose ranging studies
  • Early patient studies

3 . Phase II to Phase IV Capabilities

Experience with Phase II to Phase IV studies, ranging from single centre studies with 20 patients to large trials with over 1000 patients in multicentre.

  • Therapeutic Expertise
  • Medicine and infectious diseases
  • Chest Medicine
  • Oncology (Medical, Surgical, Radiation)
  • Nephrology
  • Neurology
  • Urology
  • Endocrinology
  • Dermatology
  • Cardiology
  • Orthopedics
  • Rheumatology
  • Gynecology
  • Psychiatry

Services

  • Protocol development
  • Feasibility services
  • Monitoring Services includes (Site Initation, Interim Monitoring and Site Closeout)
  • IMP storage & distribution services
  • Regulatory documentation

4 . Biostatistics

  • Sample size and power calculations
  • Randomization schemes
  • Development of sophisticated statistical analysis plans (SAP) including Mock Tables, Listings and Figures (TLFs)
  • Statistical programming and data analysis for PK, PK/PD, efficacy, and safety endpoints
  • CDISC compliant SAS Export Package
  • Statistical consultation and education
  • Ad hoc and retrospective analyses

5 . Data Management

  • Case Report Form (CRF) design and development
  • Database design & validation
  • Data management & validation plan preparation
  • Coding of AEs & concomitant treatments
  • Data entry validation, tabulation, control & clarification
  • Database lock
  • Data Clarification Form (DCF) Management

6 . Medical Writing

  • High quality data presentation & writing in accordance with global regulatory standards with sophisticated planning and execution
  • Experienced-based study Protocol & ICF development
  • Integrated study report writing in CTD format with hyperlinking & bookmarking
  • Preparation of FDA Summary Tables for ANDA submissions
  • Custom format reports
  • CD-ROM copy and hard copy of reports and associated study data
  • Compilations of abstracts, manuscripts, publications & poster presentations
  • Our standard reports are prepared to conform to the requirements of the ICH E3 "Structure and Content of Clinical Study Reports" in the shortest time possible.

7 . Regulatory Affairs

  • IRB/ IEC Submissions
  • Liaise with the IRB/ IEC
  • CTA preparation & filing
  • Consultation with regulatory agencies (DCGI)

8 . Other Services

  • Medical Publication
  • GCP Training
  • Contract Staffing