Clinical Life Sciences

Exelo Technologies is a full-service provider offering a multitude of service offerings to Pharmaceutical, Biotech, CRO, Medical Device & Healthcare companies across the India.

Our Life Sciences services come with processes, reporting and visibility customized to each client, across all therapeutic areas. If your needs include Monitoring, Clinical Trial Management & Support, Drug Safety or Data Management and Statistical Programming. We deliver solutions through our Managed Resources, Function Services Provider (FSP) and Project-Based Outsourcing models — helping your clinical trial stay on-target with project milestones.

We do provide services in:

  • Data Management
  • Biostatistics and SAS Programming
  • Drug Safety and Regulatory
  • Clinical Trail Management
  • Pharma Validation
  • Medical Affairs

Data Management

  • Collaborate with product, R&D and clinical team to identify data needs, define and develop a plan for data collection based on the needs.
  • Collaborate with product, clinical and engineering teams to define and develop the infrastructure and framework of the Subtle Medical data management platform.
  • Support data management activities and processes across clinical studies supported by the company.
  • Maintain and create standardized processes for data management activities.
  • Represent data management in cross-functional meetings.
  • Work with clinical physicians to appropriately label and store the data .
  • Participate in study document reviews (e.g., clinical study protocols, statistical analysis plans).
  • Work cross-functionally with other functions to meet project deliverables and timelines for clinical data collection, quality checking and reporting.
  • Ensure data system compliance by following the established regulatory guidelines.
  • This role works with PHI on a regular basis both in paper and electronic form and has an access to various technologies to access PHI (paper and electronic) in order to perform the job

 Biostatistics and SAS Programming:

  • Contribution to and review of statistical analysis plans and analysis datasets specifications.
  • Prepare the electronic submission of clinical trial data to regulatory authorities.
  • Anticipate statistical programming resource needs and work with management to ensure adequate long-term resource allocation within a project.
  • Provide effective solutions for complex statistical programming tasks.
  • Provide input or lead data standardization efforts (e.g., CRF and database design, edit checks, standard statistical programs, data presentations, data standards such as CDISC STDM/ADaM, and e-submissions).
  • Create and manage the project and study electronic subdirectories ensuring consistency in structure.
  • Contribute to the design, creation, and validation of global programming macros that streamline programming activities and increase efficiency.
  • Participate in the development of new processes or revision of existing processes.
  • Keep current with new statistical programming techniques and technological advancements.
  • As necessary, provide work direction, guidance, mentoring, influence, and support to junior staff. Train junior staff in more complex statistical programming techniques.

Drug Safety and Regulatory

  • Process SAE/AE and medical device reports into the Safety Database System performing such steps as Data Entry, Triage, Distribution, follow-up, etc. This may involve database systems such as ARIS G, ARGUS g, and TrackWise.
  • Provide administrative support to the department: schedule departmental meetings, send out agenda prior, take meeting meetings, distribute meeting minutes/action items post, any required follow-ups
  • Collaboration and communication with Data Management/Stats, Clinical Operations, Regulatory Affairs, Medical Affairs, Commercial (Sales/Marketing), and other functions as needed
  • Support Change Controls lifecycle for Safety Database Systems, utilizing in-house system as well as COTS
  • Provide support to PV SOPs (local and global), utilizing Veeva Quality Docs (VQD) – including maintenance of safety documentation in VQD.
  • Provide guidance & support, including reviewing, revising, creating Safety SOPs, Work Instructions and Quality Manuals (QM) to obtain a post-marketing milieu ready case processing and signal detection system.

Clinical Trail Management

  • Assist as required in the startup of clinical trials including support for investigator identification, investigator meetings, shipment of study supplies, collection of essential documents and preparation for site initiation
  • Assist with routine communication to study sites and broader study team (Vendors including Clinical Research Organizations (CROs) and support functions)
  • Support the CPM in development and/or improvement of study specific procedures and processes
  • Preparation, collection, processing, tracking and filing of study-related documentation, information and materials according to Good Clinical Practices and Standard Operating Procedures
  • Handle queries or issues and when necessary, promptly triage to appropriate staff. Maintain appropriate systems including the Clinical Trial Management System (CTMS) to ensure adequate and accurate tracking of study progress, maintenance of study documentation and timely production of required reports
  • Develop and maintain a basic working knowledge of relevant protocols
  • Perform other project team duties as required or delegated by the CPM
  • Act as a back-up for CPM.

Pharma Validation

  • Responsible for managing higher level, more complex GMP validation project activities at the BIAH STJ location from concept through process validation as outlined by BIAH’s Validation Master Plan (VMP) and Corporate Policies and Procedures.
  • Maintain site validation database and document systems, support feasibility studies, equipment review, selection, acquisition and upgrade.
  • Develop and maintain higher level departmental and site standard operating procedures (SOP) and training operations on quality principles.
  • Support maintenance of Validation dept. budget. Serve as backup for Validation Management when needed
  • Preparation of validation protocols, coordinating, scheduling and test execution, for areas including but not limited to Biological Production, QA, QC, Sterile Filling, Packaging & Labeling and Logistics.
  • Serve on assigned internal and external project teams (change controls, deviations, technology transfer, BPE) as a technical/compliance resource to solve quality related issues and/or support continuous improvement.
  • Support Engineering and Production Depts. in the selection, review, acquisition, and upgrade of systems and production equipment.
  • Provide technical support in developing user and functional requirements specifications, URS, FRS, for systems and equipment.
  • Assist with internal, regulatory or Corporate audits to ensure compliance with domestic and international regulations, quality requirements and guidance documents.
  • Assist with audit responses and completion of assigned CAPAs by target due dates. Included is the responsibility for making sure Validation areas are “inspection ready” at all times.

Medical Affairs

Writes and edits various documents to support Clinical Development. Such documents may include clinical study reports (CSRs), common technical document (CTD) summaries for submission to regulatory agencies, protocols, Investigator Brochures, literature reviews, study manuals, and standard operating procedures (SOPs). Assembles CSR and CTD summary appendices and narratives.