Services

Clinical Trial Monitoring: Dedicated teams of skilled and well trained clinical research professionals to provide consistent and effective monitoring and interaction with the study sites. We at PhaseON ensure highest quality review of data by conducting on-site monitoring visits to:

• a) Oversee data collection
• b) Review source documents and CRFs
• c) Ensure regulatory and study compliance

Project Management: Project Management is the most critical part of a study success focusing on providing on-time, on-budget – quality deliverables. We at PhaseON assign experienced project managers with proven experience and expertise in clinical & late stage research. The project manager is responsible for the technical and administrative aspects of the study as defined and desired by the client.

Generic drug development includes conducting Patient PK endpoint studies and also provide support to generic companies for the independent monitoring of the typical BA/BE studies. Patient PK endpoint studies are one of the most logistically challenged studies and requires a lot of planning. High level of enrollment rates combined with most stringent compliance factors as required for in-house studies. At PhaseON, we do have access to such specialized sites and have in-house expertise to ensure that the highest standards of quality and compliance are maintained. Our highly trained teams are supported by very extensive and stringent in-house SOPs for the monitoring of the patient PK studies and BA/BE studies.

We have access to highly experienced Quality Assurance personnel to ensure compliance and quality standards for all the clinical studies undertaken at PhaseON. In addition, we at PhaseON can also provide stand alone support to our clients for QA services and Audit support. Our services include QA support for:

• i. CSV (Computer Systems Validation) inclusive of safety & DM systems, laboratory systems against 21 CRF part 11 standards and GAMP standards.

In addition, PhaseON is also equipped to provide independent and extensive support for:

• i. vendor qualifications
• ii. investigator site audits
• iii. DM audits
• iv. process audits
• v. performing root cause analysis, for-cause audits, pharmacovigilance
• vi. vendor assessment based on GLP/GMP/GCP standards.

We understand the critical importance of regulatory aspects for drug development program. We have dedicated team of regulatory affairs experts who is responsible to liaison with regulatory agency to navigate the complete and accurate regulatory approval process for conduct of clinical trial. The Regulatory Affairs Team consists of individuals having in-depth knowledge of regulatory guidelines and pathway for DCGI as well as FDA, EMEA and ANVISA. The team stay updated with all the changes and modifications taking place to current regulatory guidance and most recent version of guidance. We can help you to deal with emerging regulatory issues that arise during the product development program.

Our key services include:

• i. Regulatory dossier compilation, including CTD and eCTD format
• ii. Liaison for Regulatory Approvals to conduct a clinical trial
• iii. Export NOC for biological samples for testing
• iv. Obtain approval for Import license of drugs
• v. Safety Reporting
• vi. Product Registration for Marketing Approval

We at PhaseON have a dedicated team for conducting feasibilitiy assessment even before the start of the study. This team comprises of medical and therapeutic experts. We at PhaseOn have understood that most of the delays in study startup and patient enrollment are major contributors to cost overruns in clinical trials and that a properly designed and executed feasibility study can provide a comprehensive assessment of a clinical trial's specific challenges as well as strategies to mitigate risks before startup activities begin.

It is our experience that the companies that use feasibility studies experience have witnessed a faster clinical trial accrual and significantly fewer delays in enrollment than those that forgo this assessment.

Our robust feasibility findings and strong Investigator network helps us to identify the right site for the right study. We have a database of leading KOLs and investigators across all therapeutic areas in India, Mexico and Turkey who are ICH-GCP trained and have worked with our teams in the past. This helps us to target most potential sites based on their past working experience and training. In India, we also have the unique option of deploying trained CRCs at the investigational site to assist the study team at the site. These CRCs are trained by PhaseOn before the start of the study on project specific requirements and are based at the site.

Drug storage, distribution and logistics is one of the most critical part for the success of any clinical study. We at PhaseON have mastered this area and offer proven solutions to our clients. We have an in-house state-of-the-art drug storage facility to cater to our own studies and can offer you multiple storage conditions viz. 2⁰-8⁰ C, -20⁰ C and controlled ambient storage conditions. This is supported by very robust SOPs to keep track of the inventory and distribution of study medications. PhaseOn has tie-ups with logistical partners to support distribution of study medication to sites.

We at PhaseOn understand the importance and integrity of the data that leads to the success of any clinical study program. Right from the start of the study, our team of experts work closely with our clients to ensure that the robust Data Management Plan (DMP) is in place and is developed with highest standards of quality. This is supported by our team of expert biostatisticians to develop appropriate biostatistical programs to have a Statistical Analysis Plan (SAP) in place to ensure a combined positive outcome. The current teams have access to the most current technology programs and platforms to support regulatory submission. A strong internal QC process at each critical steps ensure consistence in the quality deliverables.

Contineous training is in our culture. We at PhaseOn have taken several initiatives to ensure that our in-house team of professionals are exposed to a continued learning program. We have tailormade training modules for the CRA in terms of Advanced GCP, Therapeutic Training and Regulatory trends

In addition, as a PhaseON initiative – we organize several training modules for clinical research professionals from other pharma companies, CROs. We also conduct advanced GCP training workshops for various hospitals and ECs team members to bring up the compliance standards in India. All these training modules – both internal as well as external are based on case study discussions

PhaseOn has experts on board to advice on the regulatory pathway for the product approval. We offer consultation on the regulatory requirements on the clinical development, dossier preparation and submission to the competent authorities in respective regions. Our close connections help us to track and respond to regulatory queries in a timely manner.