WHAT WE DO

CRO

Project Management

Project management is the discipline of planning, organizing and managing resources to bring about the successful completion of specific project goals and objectives.

Our Project Management approach is based on an ongoing anticipation and management of issues, and offering proactive solutions. Through meticulous planning and co-ordination, our project management model aims to deliver projects with clear focus on providing quality backed by on time and on-cost deliverables.

Our expertise in project management is to understand & manage the value of Cost, Quality and Timelines in Clinical Research. The project management team ensures that you receive regular feedback and assessment of your project.

The project manager’s key responsibility includes the following project components:

o Efficient Project Planning & seamless execution

o Allocation of Project Resources

o Meticulous Site Identification and Assessment.

o Contract Management

o Vendor Management

o Develop Monitoring Strategy

o CRA Training

o Monitoring Trip Report Review and Submission

o Proactive Risk Management

o Quality Assurance

Clinical Trial Monitoring

Dedicated monitors who work in accordance with the sponsor’s SOP. Achieve quality data and 100 % SD verification. Monitors are experienced and well trained and have a wide range of monitoring experience in various therapeutic areas.

Clinical Trial Monitoring services include:

o Project management

o Regulatory and protocol compliance monitoring

o Obtaining local EC/IRB approvals

o Supply inventory management

o Provide clinical development plans and protocol design input

o Train Clinical Trials staff and investigators

o Advises protocol team on safety oversight

o Communication to sponsor & relevant authorities within the defined timelines

o Evaluates adverse events/SAEs and reviews safety reports

Regulatory Services

We provide expert regulatory services to our all our clients and work in consultation with them to develop customized regulatory strategies to expedite the regulatory review and approval process across Asia Pacific region. Our regulatory team has thorough industry knowledge and hands-on experience in working with different regulatory agencies and is completely equipped to handle Investigational New Drug (INDs), ethics committees and New Drug Applications (NDAs).

Services:

o Phase II, III and IV clinical trials approvals for drugs

o Pilot and pivotal studies for devices

o Import licenses for investigational products, ancillary supplies and equipments

o Export licenses for biological.

o Marketing authorizations for drugs

o Prepare and coordinate for New Drugs Advisory Committee (NDAC) and Medical Device Advisory Committee (MDAC) at Drugs Controller General India (DCGI) Office

Clinical Data Management

Our data management service has been trusted by numerous global pharmaceutical, biotech and device companies. Renowned for its excellent planning and the utilization of latest technology, the data management team ensures high quality data, quick turnaround time and accelerated solutions for our clients.
Services

o CRF designing

o Database designing and study setup

o Data entry

o Clinical coding with industry standards and client-specific dictionaries

o Reconciliation of external data

o Data validation and query resolution

o Project management of data and technical services

Data analysis

o Creating tables, listings and graphs as per regulatory compliance

o Generating reports and documentation as per regulatory requirements

Biostatistics

Our team of well experienced  biostatisticians and statistical programmers are dedicated to deliver quality services across a wide range of therapeutic areas and to all phases of clinical trials by emphasizing on process optimization and accelerate timelines while ensuring quality and research cost reduction.

Services:

o Power/Sample size estimation

o Mock tables and listings

o Edit check programming

o Analysis dataset generation

o Tables, listings and graph generation

o Statistical analysis

o Interim and final report generation

o Validation programming and quality check of reports

o Statistical reports

Medical & Scientific Writing

Amclin Life Sciences, with its experienced and efficient team, provides a complete solution for your medical writing requirements both, during the clinical phase as well as marketing phase. Our medical writers provide solutions for your regulatory submissions and publications to add value to your research work.

Services

o Regulatory

o Protocols

o Investigators Brochure

o Clinical Study Report

o Patient Documents like Informed Consent Forms

o CTD dossier preparation and submission

Pharmacovigilance

It provides coordination of clinical and post-marketing safety data collection, processing, and reporting.

o Understanding Safety surveillance for the study

o Serious Adverse Event (SAE) form and safety database design and development

o SAE collection, evaluation, classification, and reporting

o Medical case reviews

o Adverse event narratives and coding

o Regulatory report preparation and submission

Site Management

Our site management team bridges the gap between sites and sponsor/CRO in accelerating patient enrollment and effectively managing the trial from start to finish; thus ensuring smooth transit of the trials to the next phase.

We provide access to more than 100 sites and a large network of highly qualified investigators along with Government Hospitals.

Our site support model involves placement of highly qualified and trained clinical research coordinator (CRC) at each study site to assist the investigator and site staff with all day-to-day study activities.

The roles and responsibility of CRC includes:

o Ensuring accurate of data

o Site preparation for the clinical trial

o Additional staff training

o Interacting with EC/CRO/Labs/Sponsor/PI

o Maintaining clinical trial documents/records

o IP accountability

o Scheduling patients’ visits and ensuring retention till study completion

Functional Service Provider

At its inception, our pioneer engagement in this space was the first end to end offshore based Functional Service Provider approach to Clinical Development Services. Amclin has successfully replicated and now continually delivers Clinical Data Management, Statistical Programming and Medical Writing services for the pharmaceutical industry.

Amclin offering a full range of Functional Service Provider (FSP) solutions, including;

o Clinical Monitoring

o Data Management

o Biostatistics

Pharmacovigilance 


SMO

An Overview of Our Services:

Centralized Study Administration
ALS provides is one budget, one contract and one point of contact. Serving as a central point of contact for the all sites saves clients time and resources by streamlining information to our sites. This allows site identification, feasibility and study start up to occur at an accelerated pace.

GCP Trained PI and site personnel
Each site has a dedicated research staff consisting of highly trained, board certified investigators, study coordinators, patient recruiters and support staff.

Fast & Easy Feasibility Determination
Start up time is critical to the success of a clinical trial as delays translate directly into lost revenue. Sponsors benefit from our large network and efficient management. ALS’s ability to quickly identify the right sites in our network for sponsors allows a clinical trial to begin without delay. Facilitation of rapid site activation saves time and reduces costs.

Aggressive Recruitment and Retention
With 50,000 patients and continuous recruitment throughout our network, ALS is able to rapidly enroll a study with the required demographics. ALS sets itself apart with a proven record of success; sponsor trials are conducted on time and fully enrolled with the right subjects for the right study.

Prompt Document Turnaround, Centralized Invoicing and Payments
ALS’s regulatory department is in full compliance with Scheduled Y, ICH & GCP guidelines. Our highly trained and efficient staff delivers exceptional levels of service completed with the utmost professionalism and provide sponsors with reliable, quality data.

Investigator Meeting Attendance
ALS’s Investigators / Sub-Investigators are obligated to attend the Investigator Meeting. This makes it convenient for the sponsor to conduct the meeting. All protocol issues are discussed and training for the protocol is conducted. The Investigator Meeting ensures that protocols are in place and reviewed by investigators and coordinators. This permits sponsors to fore go costly and inefficient individual site feasibility visits.

Quality Assurance
All our physicians are board certified. We are compliant with SOPs, GCP and research specific requirements. Facilities and equipment are state of the art and meet the requirements of today’s demanding studies. 


Biostatistics & SAS Programming

Programming team works closely with Biostatisticians to carry out planned analyses.

Our team ensures quality control to ensure accurate results are provided to Biostatistics before final statistical review.

o Power/Sample size estimation

o Mock tables and listings

o Edit check programming

o Creation & QC of Analysis dataset

o Tables, listings and figure generation

o Statistical analysis Plan (SAP)

o Report generation- Interim & final

o Validation programming and quality check of reports

Statistical reports 


SOP Development

Standard operating procedures (SOPs) play a critical role in conducting successful trials for CRO/SMO/Site/EC/IRB.

Amclin can provide a complete package of new SOPs, or we can audit and edit existing SOPs to ensure maximum clinical effectiveness.

Amclin offers tremendous flexibility for clients. You can purchase a complete package of SOPs, or you can purchase individual SOPs as needed. We can also provide customized templates, monitoring SOPs with attached forms and templates, and staff training on SOPs. With extensive experience in procedures and clinical operations, our consultants can save you time and significantly improve project processes. 


Quality Assurance

Quality Assurance (QA) lies at the foundation of good clinical research. To ensure we conduct unbiased assessments, our organization separates the roles of QA from the operational reporting structure. Our auditors offer this same impartiality for your studies and can enhance your compliance efforts. Our QA team consists of senior auditors with expertise in GCP, GLP & GMP

Services for Sponsor/CRO:

o Investigator Site Audit

o Vendor Audit: Lab, Pharmacovigilance, Data Management, BABE centers, SMO, etc

o Trial Mater Files (TMF- inhouse file) Audit: At facility or eTMF

o GCP Audit

o Investigator and site training- As part of CAPA closure or GCP training. Our training material would be reviewed and approved by you.

Services for SMO/Sites:

o Site Audits: GCP & study specific

o Conduct and reporting of mock regulatory onsite inspections

Services for IRB/EC:

o Site Audits- study specific on behalf of EC/IRB

Development/QC of SOPs 


Site Network and Site Management

We understand that selecting the right investigators and sites to run trial is a critical success factor, which directly impacts enrollment, patient retention, data integrity, study timelines and cost.

Hence, Amclin provides sites with investigators and site staff who are not only qualified and experienced with excellent record of patient enrollment and quality but also passionate about clinical trials.

We believe that a passionate team can achieve exceptional result consistently, irrespective of the challenges.

Amclin Study Coordinator and clinical Managers as well as Investigators maintains a close knit relationship with patients, resulting in patient retention thus making sure that the study objective/ endpoint is not affected by missed visits, early withdrawal or lost to follow up.

Key differentiators 

1. Study startup & Patient recruitment: Investigator & Patient’s database: Amclin has a distinctive network of investigators and patients who are actively seeking new trial opportunities. We leverage this exclusive resource to identify sites that are ideal matches for each protocol and have the best chance for success. Thus making sure that the study start up timelines are the shortest and you get a boost in recruitment with pre-identified pool of willing patients.

We always keep a patient centric approach and truly understand that it’s the wheel which sets the whole clinical trial activities in motion at site.

2. Centralized study management: The study management is done using our innovative cloud-based CTMS. This clinical trial enhancement system used at our sites transforms the quality and effectiveness of trial management.

It serves as a single source of truth and provide real time visibility & status throughout the life cycle of a project.

It is a solution for precision feasibility, project startup, execution and close out as well as document management and

Trainings.

Our technology replaces inefficient Excel, email and paper-based processes with automated trackers and solutions

that bring trial stakeholders together.

3. Metrics driven: The below Metrics is the benchmark we have set for ourselves and we incessantly strive to live by it.

1. Feasibility response- within 5 days of receipt of feasibility request/form

2. Startup timeline: SPOC for contracts execution & within 7 days of term agreements

3. First Patient In (FPI) Timelines: We know how critical is the first patient to start the ball rolling at site < 15 days OR can be company metrics

4. Patient Recruitment- Meet target >90% studies conducted till date

5. SDV entry- within 48 hrs. of subject study visits

6. Data Quality- <5 PDs , zero major audit findings per study

7. Database closure- 100% of studies within time

4. Trained & adequate resources: GCP and regulations trained PI, CRCs, Clinical Managers as well as Internal Medical expert.

Sites with SOPs in action,

Yearly refresher GCP trainings & case study oriented training for site staffs on a regular basis.

5. Communication: We know many studies where lack of timely communication has been one of the reason for unsuccessful trial. Hence at Amclin, we clearly define the communication and escalation strategy that will be followed at our site.

eg: SPOC for Project communication with sponsor/CRO, Weekly study reports, etc.

Site Management: We also provide trained and highly experienced CRCs for trial management to sponsors & sites. Our CRCs assist the investigator and site staff with all day-to-day study activities. We employ our systems for study management even at non-networked sites, which makes sure that we are always on top of the study.

The roles and responsibility of CRC includes:

o Ensuring accurate of data

o Site preparation for the clinical trial

o EC Correspondence

o Additional staff training

o Interacting with all stakeholders- Site personnel’s, CRO, Labs & Sponsor.

o Maintaining clinical trial documents/records

o IP storage and accountability

o Scheduling patients’ visits and ensuring retention till study completion

o Providing weekly study status report to investigators.

With Amclin’s study management tools and trained personnel’s you will be not be surprised to find the following result at our sites:

o Increase in patient recruitment

o Reduction in protocol deviations

o Reduction in Data queries

o Reduction in overall trial cost 


Document Management / eTMF

Amclin understands that enormous documents are generated during clinical trials and the necessity of sponsors to make sure they are accurately and completely updated in electronic Trial Master Files (eTMF’s). Our experienced document management team undertakes review & upload of the study documents in the sponsor’s eTMF like First Docs, Interlinks, etc.

We have 2 level process- receipt, review, naming, and upload of the documents in eTMF along with 100% QC check of for quality of content and conformity to eTMF maintenance SOP.

We have a TAT (Turnaround time) of 72 hrs to upload the final documents in eTMF from the time they are received by us. It is Amclin’s persistent endeavor to always maintain the Trial Master Files in an inspection ready state. 


Regulatory Services

We have a proficient and experienced team who are always updated with the current regulatory rules and regulations.

We are adept in catering to the regulatory needs of sponsors for drug development in India.

We provide the below services for Investigational New Drug (INDs), ethics committees and New Drug Applications (NDAs):

o Phase II, III and IV clinical trials approvals for drugs

o Pilot and pivotal studies for devices

o Import licenses for investigational products, ancillary supplies and equipment’s

o Export licenses for biologicals

o Marketing authorizations for drugs

o Site and product registrations for drugs and devices

Prepare and coordinate for New Drugs Advisory Committee (NDAC) and Medical Device Advisory Committee (MDAC) at Drugs Controller General India (DCGI) Office