End to End Service Tailored to Your Needs
Project Experience
Therapeutics
We support clients in conducting Phase I-IV studies,
Investigator Initiated Studies, across various therapeutic
areas, including biologics, small molecules, bridging studies, and vaccines
Medical Device
We help conduct pilot, pivotal, and post-market surveillance
studies for medical devices in various therapeutic areas.
Bioequivalence and
Bioavailability Studies
Helps sponsors enter local market by managing and
implementing bioequivalence & bioavailability studies.
Non-interventional Studies
Gain real-world insights into therapies, understand
disease occurrence, identify risk factors, and monitor
long-term effectiveness across various therapeutic areas
Epidemiological Studies
Support clients in conducting epidemiological studies to
understand disease patterns, identify risk factors, and inform
public health strategies
Post-marketing Surveillance
Monitors safety, efficacy, and long-term outcomes after drug approval
Proven
Regulatory
Experience
100% Approval rate from
all clinical trials submitted
75 days average submission
to approval timeline
1 week or less submission
to regulatory bodies
PPR has experience with Phase I to Phase IV clinical trials and other non interventional studies on different therapeutic areas
Vaccines/Anti-infectives
Infectious Disease
Gastroenterology
Dermatology
PPR’s Strengths
End-to-end Service with extensive experience in regulatory affairs, project management, and post-trial activities including registration and marketing
Access to Pool of Experts including qualified investigators with good reputation and performance in their field
Experienced and versed in Conducting Trials including Common and Rare Diseases including Phase I to Phase IV studies and non interventional studies
Industry Leading Study Start Up Timelines
- Document Preparation
- Site Qualification Visits
- Submission Preparation
- This maybe shortened depending on the complexity of the trial
- FDA, Ethics Committee/s Submission
- Contract & Budget Negotiations
- Preparation for Site Activation
- Study Drug Importation
- Study Drug Receipt on the Site
- Site Initiation Visits
- Screening & Enrollment of Patients
- From Study Preparation to Patient Recruitment: 12-18 weeks
- All efforts will be made to make all activities in parallel and to push timelines faster